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

Catalog Number	23533503
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nail jig is missing the nail in the distal hole of the nail.This added 1-1.5 hours to the case causing everything to be done by hand.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.A recheck with the proof equipment as performed during manufacturing itself revealed the item to be working as intended.Retest with proof equipment revealed no deviations and the item was found to be working as specified.All position settings [both distal and proximal] were rechecked and successfully passed.The function of the targeting arm was still given.The alleged mis-targeting could not be reproduced.Due to the fact that nothing was reported at the time of pre-functional check performed [required per ifu] and since the device was already in use for a longer time [manufactured in 2019] it was concluded that the event was mainly based in the intra-operative procedure.However, the procedure was successfully completed by freehand technique which is always an option.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: TARGETING ARM FEMUR PF 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: 20471177
• Report Number: 0009610622-2024-00871
• Device Sequence Number: 15295934
• Product Code: HSB
• UDI-Device Identifier: 07613327338645
• UDI-Public: 07613327338645
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/17/2024

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: Health Professional
• Device Catalogue Number: 23533503
• Device Lot Number: KP433837 0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2019
• 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