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

Catalog Number	18062035
Medical Device Problem Codes	Failure to Align (2522); Positioning Problem (3009)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
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
The customer reported that: "on a final humerus nail installation, the team had great difficulty in sighting the right lateral hole.The drill bit was a bit hard to test after the nail had been mounted on the holder, but once the nail was in place on the patient, it was much more difficult to lock it in place.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device was found functional and does not match the alleged failure.The received targeting arm is having damage marks on the hole edges, material scrub-off which indicates intensive usage of the device since long period of time.Surface of the device has been worn out and scratches are clearly visible on the periphery of the device.Also, the markings have turned yellow from white, and they have got rubbed off as well indicating the device has undergone numerous cleaning cycles.A functional check was performed with the reported targeting arm, sample sleeve, drill, and nail.Every hole of the targeting arm/ nail combination was checked, and it could be confirmed that the drill passed through the holes without getting obstructed by the nail in every case.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.Based on the investigation, the root cause was attributed to a user related issue as the device was found functional and the alleged failure was not confirmed.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that: "on a final humerus nail installation, the team had great difficulty in sighting the right lateral hole.The drill bit was a bit hard to test after the nail had been mounted on the holder, but once the nail was in place on the patient, it was much more difficult to lock it in place.".

• Brand Name: TARGETING ARM T2
• 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: 19028132
• Report Number: 0009610622-2024-00125
• Device Sequence Number: 8187282
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/21/2024

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: 18062035
• Device Lot Number: KHI082074
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2008
• 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