MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA TIBIA Ø11X330MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411133S
Medical Device Problem Codes	Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	07/29/2024
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
Revision surgery due to nail breakage the recon screwdriver did not turn, and the end cap became worn.The surgeon tried to insert the screwdriver without the rod, but the tip of the screwdriver was twisted and deformed.
Event or Problem Description
Revision surgery due to nail breakage the recon screwdriver did not turn, and the end cap became worn.The surgeon tried to insert the screwdriver without the rod, but the tip of the screwdriver was twisted and deformed.Additional information - the nail did not break.Proximal tibial bone around nail breaks.
Additional Manufacturer Narrative
Correction - please refer h6 - (device code grid and clinical signs code grid), d9 - product available to stryker the reported event could not be confirmed since the device was not returned for evaluation but with provided additional information it was confirmed that there was no nail breakage.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.Based on the additional information the event is not confirmed as there is no breakage of nail in the procedure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA Ø11X330MM
• 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: 19975823
• Report Number: 0009610622-2024-00789
• Device Sequence Number: 7075733
• Product Code: HSB
• UDI-Device Identifier: 07613327290813
• UDI-Public: 07613327290813
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 Catalogue Number: 23411133S
• Device Lot Number: K03F839
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2020
• 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 Sex: Prefer Not To Disclose