MAUDE Adverse Event Report: STRYKER GMBH TORQUE LIMITING T-HANDLE T15, 4.0NM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	542034
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure an issue was observed with a pangea t15 short screwdriver shaft while using a torque limiter to place locking screws in a proximal humerus plate.After successfully placing 3-5 screws, the tip of the screwdriver shaft twisted, leaving small metal fragments in the screw head.Despite a brief 3-5 minute surgical delay to attempt removal of the fragments using a curette and bone hook, some debris remained in the patient.The surgeon expressed concern that a piece of the driver head may have cold-welded to the screw, potentially complicating future removal of the plate.Long-term complications may arise if the screw head is deformed, which would require more specialized equipment, such as a carbide drill bit or midas rex, for removal.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned.The batch record could not be reviewed because the affected device was not returned, and the lot number communicated was incorrect.No corrective action are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during a procedure an issue was observed with a pangea t15 short screwdriver shaft while using a torque limiter to place locking screws in a proximal humerus plate.After successfully placing 3-5 screws, the tip of the screwdriver shaft twisted, leaving small metal fragments in the screw head.Despite a brief 3-5 minute surgical delay to attempt removal of the fragments using a curette and bone hook, some debris remained in the patient.The surgeon expressed concern that a piece of the driver head may have cold-welded to the screw, potentially complicating future removal of the plate.Long-term complications may arise if the screw head is deformed, which would require more specialized equipment, such as a carbide drill bit or midas rex, for removal.

• Brand Name: TORQUE LIMITING T-HANDLE T15, 4.0NM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20456544
• Report Number: 0008031020-2024-00515
• Device Sequence Number: 18350557
• Product Code: LXH
• UDI-Device Identifier: 07613327614787
• UDI-Public: 07613327614787
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 542034
• Device Lot Number: OF022911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 57 YR
• Patient Sex: Male