MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT T15, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705015
Medical Device Problem Codes	Break (1069); Fracture (1260)
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
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received screwdriver was found to be broken at the tip region.The broken segment gives an impression of an oblique separation which indicates towards usage of this screwdriver in an oblique manner(non-axially), as a lever.This apparently caused the tip to break with a brittle fracture.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 the above investigation, the root cause of the issue is deemed to be user related.The nature of breakage indicates towards an inappropriate usage of the screwdriver, apparently during the surgery.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: SCREWDRIVER BIT T15, AO FITTING
• 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: 20456223
• Report Number: 0008031020-2024-00514
• Device Sequence Number: 8768164
• Product Code: LXH
• UDI-Device Identifier: 07613327091649
• UDI-Public: (01)07613327091649(10)K1A413E
• 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): 01/29/2025

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: 705015
• Device Lot Number: K1A413E
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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