MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5042S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "spontaneous fracture of the implanted gamma nail without trauma approximately 8 months after implantation." upon receipt of the returned products the locking screw was also found to be broken.
Event or Problem Description
As reported: "spontaneous fracture of the implanted gamma nail without trauma approximately 8 months after implantation." upon receipt of the returned products the locking screw was also found to be broken.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned screw could be confirmed based on the catalog # and the lot # marked.The tip of the implant is broken, the detached fragment was not returned.The broken surface of the locking screw points towards a fatigue fracture, based on the lines of rest observed.This indicates that excessive and repetitive axial loads were applied, leading to the breakage of the screw due to fatigue.The implant is heavily deformed, with flattened and deformed threads observed.This also indicates that high axial loads were applied on the implant.The failure of the locking screw is fully related to the breakage of the corresponding nail and the observations made in the other complaint of the same pi.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Pre-operative and post-operative x-rays as well as x-rays following the implant fracture were returned for inspection.The reported pertrochanteric femoral fracture could be confirmed based on the pre-operative x-rays.No particular bone condition of medical error (apart from the misaligned drilling) that could have impaired the fracture healing or led to the implant breakage could be observed.Non-union or mal-union is likely to have been the cause of the implant failure, especially given the time of implantation (8 months) and the nature of the fracture.However, the only x-ray received showing the implant failure is of low quality and does not enable a detailed view of the bone.The broken locking screw is visible on the 8 months x-ray, confirming that its breakage occured while implanted and not during the explantation.Statement from medical expert: "the assumption of a non-union and a consecutive breakage after self dynamization (distal screw breakage visible in ct scan) is likely, however, the information given in this case does not allow for any further underlying cause investigation.The second plane postoperatively and after the breakage would be necessary/helpful here." more x-rays after the implant breakage would have been necessary for a more accurate view of the patient's bone and a more detailed investigation.It is also impossible to define to what extend the observed misaligned drilling (observed on the nail) could have helped causing the breakage, as it was most certainly not the main cause of the failure.Therefore, it was not possible to clearly define a root cause to the implant failure.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17159507
• Report Number: 0009610622-2023-00207
• Device Sequence Number: 20621644
• Product Code: HSB
• UDI-Device Identifier: 04546540382344
• UDI-Public: 04546540382344
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1896-5042S
• Device Catalogue Number: 18965042S
• Device Lot Number: K0E11F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male