MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA TIBIA Ø10X240MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411024S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: during nail removal surgery, after end cap removal, the advanced locking screw which was inserted to the second hole from proximal end of the nail was pulled out with a screwdriver, and when about 5 mm was pulled out, it started spinning and could not be pulled out any further.Only this screw was inserted proximal to the nail.After that, the surgeon attached a self-retaining screwdriver sleeve to the screwdriver, gripped the screw head, and pulled it while turning the screwdriver, but it kept spinning.After spending about 15 minutes, the screw could not be pulled out, so the surgeon gave up the removal of the screw and the nail.The self-retaining screwdriver sleeve attached to the screw head was attached quite rigidly, and he tried to turn it to remove it but had a hard time because he could not transmit force properly.10 minutes were spent to remove the screwdriver from the screw head, only the distal screws were removed.

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA Ø10X240MM
• 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: 20898310
• Report Number: 0009610622-2024-00949
• Device Sequence Number: 17394510
• Product Code: HSB
• UDI-Device Identifier: 07613327290721
• UDI-Public: 07613327290721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• 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
• Report Date (Section B): 12/10/2024

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: 23411024S
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female