MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061008
Medical Device Problem Codes	Failure to Align (2522); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
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: "target device shows signs of wear.Misdrilling occurred during surgery.Assembly outside the or - all products appear to work.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was returned and found to be functional.The received items show traces of a long and intense use identified by the general appearance of the surface.The targeting arm shows signs of frequent usage as the general appearance of the white printings, which turned from white to fawn, is an indication of high sterilization cycles.The nail handle shows signs of frequent and intense use from the scratches and dent marks available on the device.A functional inspection was performed with the received targeting arm, fixation screw, nail handle, sample nail and drill.All nail holes of a sample nail were passed by a sample drill without nail contact; the reported misdrilling was not reproducible.Sample nails could be assembled and disassembled as intended.The alleged guidance inaccuracy could not be reproduced.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.Referring to the very long period since manufacturing [manufactured in 2010] the device has fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.Based on the investigation and nothing reported during pre-operative check [required per ifu] the root cause can be attributed to user related.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "target device shows signs of wear.Misdrilling occurred during surgery.Assembly outside the or - all products appear to work.".

• Brand Name: TARGETING ARM T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18511357
• Report Number: 0009610622-2024-00032
• Device Sequence Number: 7056989
• Product Code: LXH
• UDI-Device Identifier: 04546540196576
• UDI-Public: 04546540196576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 18061008
• Device Lot Number: KME902720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2010
• 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