MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250320S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2024
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 on a supplemental report.
Event or Problem Description
As reported: "we had an incident yesterday at overland park regional.We were using a right gamma nail and the gamma nail is labeled as a 10 by 320 by 125 for the right side.Unfortunately, we put the nail in and realized that it was going to be too short, so they pulled the nail back out.When we measured the nail with a ruler, it was measured closer to 305, which is much shorter than the 320 that it was labeled as the nail, the sticker and the box all said 320, but the actual length of the nail is shorter.".
Event or Problem Description
As reported: "we had an incident yesterday at (b)(6).We were using a right gamma nail and the gamma nail is labeled as a 10 by 320 by 125 for the right side.Unfortunately, we put the nail in and realized that it was going to be too short, so they pulled the nail back out.When we measured the nail with a ruler, it was measured closer to 305, which is much shorter than the 320 that it was labeled as the nail, the sticker and the box all said 320, but the actual length of the nail is shorter.".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.With given details no discrepancy for the nail in question could be identified.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X320MM X 125°
• 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: 21030132
• Report Number: 0009610622-2024-00991
• Device Sequence Number: 14483221
• Product Code: HSB
• UDI-Device Identifier: 04546540375339
• UDI-Public: (01)04546540375339(11)210712(17)260630(10)K03F7DB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 34250320S
• Device Lot Number: K03F7DB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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: Unknown