MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X360MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34301360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported, it was decided for a nail/screw removal due to nail gamma 3 breakage.Implant date (b)(6) 2024.(normal weight patient).
Event or Problem Description
As reported, it was decided for a nail/screw removal due to nail gamma 3 breakage.Implant date (b)(6) 2024.(normal weight patient).
Additional Manufacturer Narrative
Correction - please refer to d4 lot #.The reported event could be confirmed with the provided image in which we can see the nail breakage.A review of the device history was not possible because the provided lot number seems to be incorrect as it is not available in the database.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the correct lot number was not communicated.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.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X360MM X 130°
• 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: 19849878
• Report Number: 0009610622-2024-00719
• Device Sequence Number: 6746933
• Product Code: HSB
• UDI-Device Identifier: 07613252273981
• UDI-Public: 07613252273981
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 34301360S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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: Required Intervention
• Patient Sex: Unknown