MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533103
Medical Device Problem Codes	Naturally Worn (2988); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
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: "item 23533103 targeting arm returned to the nordic kitroom with peeling glue from moisture getting under it and there's is now a small gap where bacteria can grow.The item is not fit for live surgery.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned targeting arm was confirmed based on the catalog # and the lot # marked.The reported residue that looks like "peeling glue from moisture" could be confirmed on the device, in the gap under and above the block with targeting holes.The residue could not be observed on any other part of the instrument.Based on investigation, the root cause was attributed to an user related issue.The residue observed is most probably a result of the repetitive accumulation of moisture in the gap after the multiple sterilization/cleaning cycles the instrument underwent during almost 5 years of use.It is probable that the instrument was not properly dried after some of these cycles, resulting into the residue observed.It must be noticed that no similar event has been reported for other devices of the same catalog.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "item 23533103 targeting arm returned to the nordic kitroom with peeling glue from moisture getting under it and there's is now a small gap where bacteria can grow.The item is not fit for live surgery.".

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• 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: 18693749
• Report Number: 0009610622-2024-00067
• Device Sequence Number: 8358415
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K203819
• 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): 05/20/2024

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: 23533103
• Device Lot Number: KP431228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown