MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5055S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2022
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
A screw breakage was reported.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could be confirmed, as the device was not returned for evaluation but an image was shared which confirms the alleged failure.On provided x-ray copies, dated october 31, 2022, screw breakage was confirmed in a-p-view.The broken locking screw was positioned at the static mode of the oblong drill hole.A second screw in the static drill hole was not apparent.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.In the case presented a 52-year-old male patient had been treated with above implant on an unknown date.On october 31, 2022 the screw was revised due to breakage.Four x-ray copies, dated october 31, 2022 in a-p- and m-l-views were provided.These were sent to a hcp for review.His comments in excerpts: "provided x-rays show a self-dynamization, broken screw, at distal.At proximal the x-rays only allow an assumption that the fracture is in progressing union now.A ct-scan would probably give a safer view.A) the positioning of the lag screw is at least remarkable.In both planes it is not in centered position as advised in the labeling and it seems that it has not been achieved by having an optimized tip apex distance -tad.B) the distal locking is either static locking - in that case a second locking screw would have been mandatory or dynamic locking.In that case it would have been recommendable to choose the dynamic locking option".If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
A screw breakage was reported.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15851577
• Report Number: 0009610622-2022-00554
• Device Sequence Number: 17773504
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: 04546540202529
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 1896-5055S
• Device Catalogue Number: 18965055S
• Device Lot Number: K0AA522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Male