SCREW, FIXATION, BONE
Report
- Report Number
- 2520274-2015-17680
- Event Type
- Injury
- Date Received
- December 4, 2015
- Report Date
- November 13, 2015
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
Narratives
DATE OF POSTOPERATIVE DEVICE BREAKAGE IS UNKNOWN; HOWEVER, IT WAS REPORTEDLY DISCOVERED TWO (2) WEEKS AFTER THE IMPLANT PROCEDURE. THIS REPORT IS FOR ONE (1) UNKNOWN 4.0 CANCELLOUS SCREW. DEVICE WAS NOT FULLY EXPLANTED DURING THE REVISION PROCEDURE, WHICH TOOK PLACE ON AN UNKNOWN DATE. THE RETRIEVED PORTION OF THE BROKEN SCREW IS EXPECTED TO BE RETURNED FOR MANUFACTURING REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(6). A PARTIAL PART NUMBER (206.0XX) WAS IDENTIFIED DURING THE INVESTIGATION OF THE RETURNED DEVICE. BASED ON THE PARTIAL PART NUMBER, THE FOLLOWING INFORMATION CAN BE DERIVED: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED (VARIETY OF LENGTHS). PRODUCT CODES ASSOCIATED WITH THIS DEVICE INCLUDE: HRS ¿ PLATE, FIXATION, BONE; HWC ¿ SCREW, FIXATION, BONE. BASED UPON THE PARTIAL PART NUMBER (206.0XX), THE LIKELY 510K NUMBER FOR THIS SCREW IS K083213. PRODUCT INVESTIGATION SUMMARY: THE RETURNED SCREW WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE SCREW SHAFT WAS BROKEN APPROXIMATELY 23.5MM FROM THE SCREW HEAD. NO DEFINITIVE ROOT CAUSE IS ABLE TO BE IDENTIFIED WITH THE PROVIDED INFORMATION. THE 4.0MM STAINLESS STEEL CANCELLOUS BONE SCREW (206.0XX) IS NOTED IN FIVE TRAUMA SYSTEM TECHNIQUE GUIDES: SMALL FRAGMENT LOCKING COMPRESSION PLATE, SELECT COMPACT ANKLE FRACTURE, 3.5MM LCP DISTAL TIBIA T-PLATES, 3.5MM LCP PILON PLATES AND 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES. THE RETURNED SCREW WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE SCREW SHAFT WAS BROKEN APPROXIMATELY 23.5MM FROM THE SCREW HEAD. NO DEFINITIVE ROOT CAUSE IS ABLE TO BE IDENTIFIED WITH THE PROVIDED INFORMATION. THE RELEVANT DRAWING FOR THE RETURNED SCREW FAMILY WAS REVIEWED. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED FOR THE RETURNED INSTRUMENT, AS PART/LOT INFORMATION WAS UNAVAILABLE. NO DEFINITIVE ROOT CAUSE IS ABLE TO BE IDENTIFIED WITH THE PROVIDED INFORMATION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT A 4.0 FULLY THREADED CANCELLOUS SCREW WAS IMPLANTED DURING A HALLUX INTERPHALANGEAL JOINT (IPJ) FUSION PROCEDURE ON (B)(6) 2015. THE SCREW REPORTEDLY BROKE APPROXIMATELY TWO (2) WEEKS LATER. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNKNOWN DATE. THE SURGEON RETRIEVED THE DISTAL PORTION OF THE SCREW AND SUCCESSFULLY PINNED THE TOE. THE PROXIMAL PORTION WAS INTENTIONALLY LEFT IN SITU AS THE SURGEON DID NOT WANT TO DESTROY OR COMPROMISE THE PATIENT'S PROXIMAL PHALANX TRYING TO REMOVE IT. THE SURGEON BELIEVES THAT THE PATIENT WAS "A LITTLE TOO ACTIVE," CAUSING THE SCREW TO BREAK AS A RESULT OF MICRO-MOTION. THIS REPORT IS FOR ONE (1) UNKNOWN 4.0 CANCELLOUS SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796807 | SCREW, FIXATION, BONE | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |