MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA TIBIA Ø9X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23410930S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned and no additional information was available.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : implanted.
Event or Problem Description
As reported: "advanced locking screw bound up in alpha tibia nail.Would not advance or back up.Cut screw tip with bolt cutter.Screw prominent.May need additional surgery to remove.Revision surgery is planned, but not yet scheduled.Bone quality seemed normal.The locking screw was placed in the proximal, oblique hole of the jig and into the nail.".

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA Ø9X300MM
• 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: 19188047
• Report Number: 0009610622-2024-00171
• Device Sequence Number: 7148122
• Product Code: HSB
• UDI-Device Identifier: 07613327290875
• UDI-Public: 07613327290875
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: Health Professional
• Device Catalogue Number: 23410930S
• Device Lot Number: K0474C7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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: 71 YR
• Patient Sex: Female