MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23311234S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "in stryker cdc venlo during inbound processing, it was reported that there is a hair on the product underneath the foil.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.The device inspection revealed the following: the product was received with intact packaging.The shrink foil was wrapped properly, and it looks like that the box was not opened.A hair under the overwrap foil outside the box was seen without opening the box in packed condition which confirms the reported event.Based on investigation, the root cause was attributed to be a manufacturing related issue as the package was having the hair under the overwrap shrink foil due to deficiency in one of the manufacturing processes.A former event had already triggered an nc for the current occurrence which resulted in some actions (capa).In the implemented capa, multiple actions were taken and deemed as effective.The reported device in current occurrence was manufactured prior to the actions taken.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "in stryker cdc venlo during inbound processing, it was reported that there is a hair on the product underneath the foil.".

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X340MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22018408
• Report Number: 0008031020-2025-00889
• Device Sequence Number: 9484803
• Product Code: HSB
• UDI-Device Identifier: 07613327284379
• UDI-Public: (01)07613327284379(11)240919(17)340831(10)K1D9222
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191271
• 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): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 23311234S
• Device Lot Number: K1D9222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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
• Patient Sex: Unknown