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

Catalog Number	18062035
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2024
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: "problems occurred during surgical procedure due to carbonic centering device".
Event or Problem Description
As reported: "problems occurred during surgical procedure due to carbonic centering device".
Additional Manufacturer Narrative
Please note correction to section h6 (device code).The reported event could be confirmed, since the affected device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following : the received targeting arm t2 prox.Hum.Shows significant signs of severe usage evident by the appearance of damaged holes.Lateral left (ap ¿ locking) & lateral right holes found damaged.Line and dent marks are visible on the tip of locking clamp.Entry point / edges of the holes are damaged by the action of sharp instruments like sleeves.Lever of the lateral left/right sleeve locking mechanism is deformed i.E.Bent from one side and uplifted from other side.Lateral left (ap ¿ locking) sleeve is found misaligned.This shows that these portions of the instruments had been subjected to abnormal loading.A functional inspection was carried out and we found that the drill was not passing through the proximal holes of the sample t2 proximal humerus nail using the received target device.This is because of the deformation and damaged holes observed in the targeting device during visual inspection.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, it can be confirmed that the observations found during device inspection are result of abnormal handling of the instrument.Therefore, the root cause was attributed to a user related issue.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• 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: 18686738
• Report Number: 0009610622-2024-00064
• Device Sequence Number: 20432015
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/23/2024

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: KHI018022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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