MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE, HUMERUS T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060143
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
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: "incorrect drilling during proximal locking t2 humerus.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device returned for evaluation was found damaged and is not recommended for usage as clearly stated in ifu.The device inspection revealed the following: in the received targeting device, signs of repetitive usage are visible as evidenced by worn out surface of the device.Markings on the device has turned fawn from white which indicates that the device has gone through numerous cleaning cycles.Overall, the device is in pretty much used condition.A portion of target device between proximal holes of locking mechanism found broken.A linear crack is clearly visible near the proximal hole and edges of the proximal holes are also worn out.This suggests that the proximal holes of the locking mechanism have experienced lateral stress during usage over a long period which led to gradual degradation of the surface and ultimately caused breakage.As the device is found damaged and it is not recommended for use in such condition as per ifu , therefore a functional inspection was not considered necessary.The device should be checked before the surgery and that it was most probably already broken before.The pre-op check was most probably not done.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a wear related issue as the device has failed due to lateral stress acting on the device during usage over long period combined with numerous cleaning and sterilization cycles.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "incorrect drilling during proximal locking t2 humerus.".

• Brand Name: TARGET DEVICE, HUMERUS 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: 19435229
• Report Number: 0009610622-2024-00257
• Device Sequence Number: 12842467
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• 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): 08/27/2024

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: 18060143
• Device Lot Number: KP215642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2005
• 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