EXACTECH
Report
- Report Number
- 1038671-2021-10029
- Event Type
- Malfunction
- Date Received
- February 16, 2021
- Date of Event
- October 5, 2017
- Report Date
- February 22, 2021
- Manufacturer
- EXACTECH, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020) AND A PORTION OF COMPLAINTS FROM 2013-2017. THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. H11. H6. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE TIBIAL TAMP HEAD DISASSEMBLED FROM THE TIBIAL TAMP GUIDE AFTER THE SURGEON PERFORMED THE TIBIAL PUNCH STEP. AS A RESULT, THE TIBIAL TAMP HEAD WAS REMOVED FROM THE PATIENT'S TIBIA WITH SURGICAL PLIERS RATHER THAN THE TIBIAL TAMP GUIDE." ADDITIONAL INFORMATION PROVIDED IDENTIFIED "AN INITIAL INSPECTION OF THE TAMP HEAD SHOWS SIGNS OF DEFORMATION DUE TO MISUSE, LIKELY DUE TO RETROGRADE IMPACTION. THE REP STATED IT'S POSSIBLE THE TAMP HEAD WAS FROM A LOANER SET THAT BECAME MIXED IN WITH HIS CONSIGNMENT SET AND THAT THE POTENTIAL MISUSE OCCURRED THROUGH A DIFFERENT SOURCE. THE TAMP HEAD APPEARS TO BE DEFORMED AND NOT FRACTURED." DESIGN: THE DESIGN OF THE TAMP HEAD HAS BEEN IN THE FIELD SINCE 2010. 48 COMPLAINT REPORTS INVOLVING 49 TIBIAL TAMP HEAD DUE TO MALFUNCTION OF THE MATING FEATURE (FRACTURED, DEFORMATION, NOT REPORTED) SINCE 2010. SINCE THE TAMP HEAD IS USED IN PREPARATION FOR THE TIBIAL TRAY, THE SALES DATA FOR ALL LOGIC TIBIAL TRAYS WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <0.5%. THIS IS CONSIDERED "VERY LOW" ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. THEREFORE, THIS DOES NOT APPEAR TO BE DESIGN RELATED. MANUFACTURING: 1 OTHER COMPLAINT INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 30 UNITS, WHICH HAS BEEN IN THE FIELD SINCE 2016. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON A PREVIOUS COMPLAINT INVESTIGATION, SHOWED THAT THE NAMED DEVICES WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE REQUIREMENTS. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING-RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT AND RISK ASSESSMENT AND CONTROLS REPORT WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THE DISASSEMBLY REPORTED WAS LIKELY DUE TO DEFORMATION OF THE TAMP HEAD MATING FEATURE AS A RESULT OF MISUSE THROUGH RETROGRADE IMPACTION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING OR DESIGN ISSUES, NOR LED TO ANY PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED: THE DISASSEMBLY REPORTED WAS LIKELY DUE TO DEFORMATION OF THE TAMP HEAD MATING FEATURE BECAUSE OF MISUSE THROUGH RETROGRADE IMPACTION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. H10. UPDATED/ADDED- B4., G6., H2., & H11.
AS A RESULT OF AN FDA INSPECTION CONDUCTED IN (B)(6) 2020, EXACTECH HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020) AND A PORTION OF COMPLAINTS FROM 2013-2017. THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THIS ISSUE WAS INVESTIGATED UNDER A CAPA, AN ENGINEERING INTAKE FORM WAS FILLED OUT AS THE INVESTIGATION. THE BROKEN TIBIAL TAMP WAS LIKELY THE RESULT OF EXCESSIVE FORCE BEING APPLIED UPON REMOVAL WHICH LED TO A BRITTLE FRACTURE. THE DESIGN OF THE DEVICE HAS BEEN UPDATED AFTER THE MANUFACTURE DATE OF THIS SERIAL NUMBER TO INCLUDE A BLEND RADIUS ON THE UNDERSIDE OF THE LIP WHERE THE FRACTURE OCCURRED. THIS BLEND IS INTENDED TO AID IN DISTRIBUTING THE APPLIED FORCE THROUGH THE SHAFT OF THE DEVICE, MINIMIZING THE FORCE CONCENTRATION AT THE LIP. AN INVESTIGATION WAS CONDUCTED UNDER CAPA2 (B)(4): THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE TIBIAL TAMP HEAD FRACTURES WAS A COMBINATION OF THE DESIGN AND A USER MISUSE ISSUE. REVISION A OF THE TIBIAL TAMP HEAD HAS A SHARP CORNER PRESENT THAT COULD CREATE A STRESS CONCENTRATION THAT CONTRIBUTES TO THE BREAKAGE OF THE DEVICE. THE SURGICAL TECHNIQUE INSTRUCTS THAT USE OF THE EXTRACTION LEVER AND "MAULDIN MULTI-TOOL" SHOULD BE USED TO EXTRACT THE TIBIAL TAMP HEAD FROM THE BONE. THE SURGICAL TECHNIQUE DOES NOT SPECIFICALLY STATE THAT THE SURGEON SHOULD NOT HIT THE TAMP HANDLE/GUIDE BACKWARDS (RETRO-GRADE) TO REMOVE THE TAMP ASSEMBLY FROM THE BONE. AS A CORRECTION, EXACTECH HAS UPDATED THE SURGICAL TECHNIQUE TO CLARIFY THE PROPER TECHNIQUE AND INSTRUMENTATION TO REMOVE THE TAMP ASSEMBLY FROM THE BONE, I.E., TO INCLUDE A CAUTION STATEMENT ABOUT THE POTENTIAL FOR INSTRUMENT BREAKAGE IF THE TAMP HANDLE/GUIDE IS MISUSED BY IMPACTING IN RETRO-GRADE. ADDITIONALLY, THE DESIGN OF THE DEVICE WAS MODIFIED TO ADD A RADIUS TO WHERE THE SHARP CORNER WAS LOCATED, TO REDUCE THE STRESS CONCENTRATION. THE CAPA INVESTIGATED COMPLAINT DATA TO COMPARE OCCURRENCE RATE OF DEVICE FRACTURES FOR REVISIONS A AND B OF THE TIBIAL TAMP HEAD. THERE WERE NO COMPLAINTS FOR DEVICE FRACTURE FOR REV. B OF THE TAMP HEAD AT THE TIME OF THE INVESTIGATION INDICATING A LOWER OCCURRENCE FOR DEVICE FRACTURE AND IMPROVED EFFECTIVENESS. EXACTECH IFU 700-096-004 STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: APPROPRIATE READING OF THE LITERATURE AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR TOTAL KNEE ARTHROPLASTY SURGERY, AND REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. HTTPS://WWW.EXAC.COM/WP-CONTENT/UPLOADS/2020/07/712-25-31_REVD_LOGIC_LPI_CRPS_OPTECH-1.PDF: OPTETRAK OPERATIVE GUIDE STATES: THE TAMP SHOULD BE EJECTED FROM THE PROXIMAL TIBIA BY SQUEEZING THE RELEASE LEVER. IF THE TAMP GUIDE DOES NOT DISENGAGE FROM THE TIBIA WITH THE RELEASE LEVER, A MAULDIN MULTI - TOOL CAN BE USED TO DISENGAGE IT BY INSERTING THE SMALL STUD ON THE END OF THE MAULDIN MULTI-TOOL INTO THE HOLE IN THE HANDLE OF THE TAMP, THEN ROTATING THE MAULDIN MULTI-TOOL TO LOOSEN THE TIBIAL TAMP. DO NOT HIT THE TAMP IN RETROGRADE. HITTING THE TAMP IN RETROGRADE CAN RESULT IN BREAKAGE OF THE INSTRUMENT. IT IS A CLINICAL STANDARD OF PRACTICE PROCEDURE IN THE OPERATING ROOM THAT ALL INSTRUMENTS SHOULD BE VISUALLY AND FUNCTIONALLY INSPECTED BEFORE USE, THESE GUIDELINES ARE FROM STANDARD ASSOCIATION OF PERI-OPERATIVE REGISTERED NURSES (AORN) GUIDELINES. SURGEONS ARE TO BE FAMILIAR AND KNOWLEDGEABLE WITH ALL EXACTECH INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED INSTRUMENT MALFUNCTION IS RELATED TO ANY MANUFACTURING ISSUES OR LED TO ANY PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED UNDER CAPA2 (B)(6); THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE TIBIAL TAMP HEAD FRACTURES WAS A COMBINATION OF THE DEVICE DESIGN AND USER ERROR.
IT WAS REPORTED THAT DURING AN ORTHOPEDIC KNEE SURGERY THE SURGEON EXPERIENCED A TIBIAL TAMP GUIDE THAT WOULD NOT REMOVE THE TAMP HEAD DUE TO THE TAMP HEAD BEING BROKEN. THE DEVICE MALFUNCTION OCCURRED DURING THE REMOVAL OF THE TAMP AFTER THE KEELING PROCESS. THE SALES REPRESENTATIVE WAS PRESENT AT THE SURGERY AND REPORTED NO DEVICE FRAGMENTS FELL INTO THE SURGICAL SITE. THE SURGERY CONTINUED AND WAS COMPLETED WITHOUT ADDITIONAL ISSUES. THERE WAS MINIMAL DELAY OF SURGERY, THERE WAS NO PATIENT INJURY, ADVERSE EVENT, OR CLINICAL CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231997 | EXACTECH | COMBO TRAY ADJUSTABLE TIBIAL TAMP HEAD, NET SHAPE | LXH | EXACTECH, INC. | 73194008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |