MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X80MM; SCREW, FIXATION, BONE

Model Number	2361-5080S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "advanced locking screws backing out".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the migration of the locking screw is visible on the received x-rays.A device inspection was not possible since the affected device was not returned.A review of the device history was not possible because the correct lot number for the reported catalog number was not communicated.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.The complaint was forwarded to medical affairs for review with following feedback: ¿the fracture has no stability at all with just a nail.This borderline indication has resulted in material failure due to the catastrophic fracture morphology with several fragments.The stability that was not achieved then led to micro-movements and the screw backing out by a small wiper movement of the quasi-loose distal joint fragment.A material combination with free screws and nail/plate construct, possibly also with cerclage, would have been a better option in this case.¿ based on investigation, the root cause was attributed to a user related issue.The back out of the locking screw was caused by the above described instable fracture situation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "advanced locking screws backing out".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X80MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 15120469
• Report Number: 0009610622-2022-00348
• Device Sequence Number: 12162932
• Product Code: HWC
• UDI-Device Identifier: 07613327381580
• UDI-Public: 07613327381580
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2361-5080S
• Device Catalogue Number: 23615080S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 102 KG