RSP SHOULDER
Report
- Report Number
- 1644408-2015-00100
- Event Type
- Malfunction
- Date Received
- February 26, 2015
- Date of Event
- February 19, 2015
- Report Date
- February 19, 2015
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
INSTRUMENT 804-03-048 CONSISTS OF THREE COMPONENTS: 1) DRILL GUIDE 2) SCREW GUIDE 3) THUMB SCREW, TWO COMPONENTS (THE DRILL GUIDE & SCREW GUIDE) OF THE INCIDENT DRILL GUIDE WERE RETURNED WITH RPR # Q915804 ON 17 JUN 2015. THE RETURNED COMPONENTS WERE VISUALLY INSPECTED. OVER ALL, THE INSTRUMENT IS IN GOOD CONDITION WITH MINOR SCRATCHES AND WEAR MARKS INDICATIVE OF EXTENDED REGULAR USE. THE THUMB SCREW WAS NOT RETURNED. THE INCIDENT DRILL GUIDE PRINT SPECIFIES THE LENGTH OF THE THUMB SCREW SHAFT WITH THE THREADED TIP INCLUDED IS .620" +/- .010 AND THE THREADED TIP IS .115" +/- .005" LONG AND THE DIAMETER OF THE SHAFT IS ONLY .100"+.005/-.000 WHICH CAN SHEAR/FRACTURE WHEN SUBJECTED TO EXCESSIVE TORQUE OR BENDING. THE BROKEN SCREW IS MADE FROM 17-4 PH STAINLESS STEEL, AND IS DESIGNED TO BE .870" LONG, WITH A 6-32 UNC-2A THREADED CONNECTION. THE THUMB SCREW DESIGN INCLUDES A KNURLED KNOB TO TIGHTEN BY HAND BUT ALSO AN INTERNAL HEX MAKING IT POSSIBLE TO TIGHTEN WITH A HEX DRIVER. THIS ALONG WITH THE SMALL THREADED TIP (6-32) MAKES THE THREADED TIP SUSCEPTIBLE TO DAMAGE IF OVER TIGHTENED. THE THUMB SCREW ONLY NEEDS TO BE HAND TIGHTENED UNTIL SNUG TO PROPERLY SECURE THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE MAIN COMPONENT LISTED IN THE COMPLAINT. THE DRILL GUIDE WAS RELEASED FROM MANUFACTURE AROUND SEPTEMBER, 2012; THEREFORE IT IS POSSIBLE IT MAY HAVE BEEN IN SERVICE FOR 2.5 YEARS. THE THUMB SCREW THREADS 6-32 UNC-2A WERE SAMPLE INSPECTED (5 OF 20) WITH A THREAD GAGE DURING RECEIVING INSPECTION AND FOUND ACCEPTABLE. THE SHAFT DIAMETER OF .100 WAS NOT INSPECTED. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THERE WERE 70 PRIOR COMPLAINTS ON PART NUMBER 804-03-048, RSP BASEPLATE DRILL GUIDE AND 44 PRIOR COMPLAINTS ON THUMB SCREW THREAD BROKEN/STRIPPED ISSUE AND 8 COMPLAINTS ON THUMB SCREW CROSS THREADED ISSUE. REST OF THE COMPLAINTS WERE RELATED TO MISSING FEATURE OR LOST. COMPLAINT HISTORY DOES NOT INDICATE ANY ADDITIONAL ADVERSE TREND. CONTAINMENT ACTION WAS HANDLED BY HEALTH HAZARD EVAULAUTION (HHE) HHE 2012-00013 AND CORRECTIVBE AND PREVENTATIVE ACTION (CAPA) (B)(4). THE MATERIAL OF THE THUMB SCREW HAS BEEN CHANGED TO 465SS (REV C TO REV D) IN MAY OF 2013, WHICH WILL ENHANCE THE PERFORMANCE. SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO DAMAGE FROM EXTENDED USAGE, EXPOSURE TO HIGH TORQUES, OR REPEATED USE IN MANY SURGERIES. THE ROOT CAUSE OF THE FRACTURE CANNOT BE DETERMINED WITH CERTAINTY BUT IS MOST LIKELY CAUSED BY OVER TIGHTENING OF THE SCREW USING A HEX DRIVER OR IMPROPER ORIENTATION OR CROSS THREADING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE AS RECOMMENDED IN THE INSTRUMENT IFU 0400-0146, "RECOMMENDATIONS FOR THE CARE AND HANDLING FOR DJO SURGICAL INSTRUMENTS AND INSTRUMENT CASES"
THIS REASON FOR THIS PRODUCT COMPLAINT WAS TO REPORT THE GLENOID DRILL GUIDE FRACTURING OFF IN THE BASEPLATE AND THE SURGEON NOT BEING ABLE TO IMPLANT THE GLENOID RETAINING SCREW DUE TO THE SCREW FROM THE GLENOID DRILL GUIDE BEING STUCK IN THERE. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS A 60 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE HAS NOT BEEN MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. TO DATE THE DRILL GUIDE, TWO PIECE, RSP HAS NOT BEEN RETURNED FOR INVESTIGATIONAL REVIEW AS OUTLINED IN SALES POLICY #4403 AFTER ISSUANCE OF THE RETURN PRODUCT RECEIPT# (B)(4). IT HAS BEEN IN EXCESS OF 59 DAYS FROM THE DATE CREATED AND THE AGENCY DID INDICATE THAT THE INSTRUMENT WOULD BE RETURNED FOR EVALUATION. THE LOT NUMBER OR REVISION LEVEL WERE NOT REPORTED; THEREFORE, THIS INSTRUMENT COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD(S) (DHRS) AND THE ACTUAL DATE OF MANUFACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. INSTRUMENTS ARE SUBJECTED TO HEAVY USE/MISUSE/WEAR AND CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE. REFER TO INSTRUMENT IFU 0400-0146 "RECOMMENDATIONS FOR THE CARE AND HANDLING FOR DJO SURGICAL INSTRUMENTS. THE CONDITION OF SURGICAL INSTRUMENTS CAN BE DETERMINED BY WEAR AND DAMAGE INCURRED WHILE BEING USED FOR ITS INTENDED PURPOSE. THE REPLACEMENT OF INSTRUMENTS DUE TO NORMAL WEAR AND TEAR DOES NOT INDICATE A PRODUCT DEFICIENCY, FAILURE OR ISSUE. NO FURTHER EVALUATION CAN BE MADE FOR THIS EVENT. IN THE MEANTIME THIS PRODUCT COMPLAINT WILL BE CLOSED. IF THE INSTRUMENT IS RETURNED AND IT WARRANTS AN INVESTIGATION THE COMPLAINT WILL BE OPENED TO PROCESS AND EVALUATE THE INITIAL PROBLEM. IF IT IS DEEMED TO BE A WORN INSTRUMENTATION AN EVALUATION WILL BE PERFORMED AND ADDED TO THE FILE.
REVISION SURGERY - THE SCREW ON THE GLENOID DRILL GUIDE FRACTURED OFF IN THE BASEPLATE AND WAS LEFT IN THE PATIENT. THE SURGEON WAS NOT ABLE TO IMPLANT THE GLENOID RETAINING SCREW DUE TO THE SCREW FROM THE GLENOID DRILL GUIDE BEING STUCK INSIDE THE PATIENT.
INSTRUMENT FAILURE - THE SCREW ON THE GLENOID DRILL GUIDE FRACTURED OFF IN THE BASEPLATE AND WAS LEFT IN THE PATIENT. THE SURGEON WAS NOT ABLE TO IMPLANT THE GLENOID RETAINING SCREW DUE TO THE SCREW FROM THE GLENOID DRILL GUIDE BEING STUCK INSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137492 | RSP SHOULDER | DRILL GUIDE, TWO PIECE, RSP | LXH | ENCORE MEDICAL, L.P. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention |