MAUDE Adverse Event Report: STRYKER GMBH STERILE WRIST KIT MONOTUBE TRIAX 15MM X 200MM; PIN, FIXATION, THREADED

Model Number	5150-9-960
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The surgeon placed 2x 3mm apex pins in the left 2nd metacarpal and midway in the radius.The triax monotube from a sterile wrist kit was placed over the pins.The surgeon reduced the fracture and tightened the bolts on the proximal pin clamp followed by the bolts on the distal pin clamp.The pin clamp on the distal pins was loosened to make further adjustments then all bolts were tightened again.Once the surgeon tried to loosen the flexion/extension control on the distal pin clamp, the bolt broke.A portion of the bolt remained in the pin clamp and another portion along with the head of the bolt was separated from the clamp.The 4 apex pins were removed and surgeon splinted the patient under x-ray.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an over-tightening of the device.The device was inspected and the inspection revealed that the bolt-screw was over-tightened with a large torque so that the screw broke at the thread level.Therefore, this is an application error.A functional inspection is held for all the items in order to ensure that the parts are conforming to specifications.The device received by the customer was then fully functional.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The surgeon placed 2x 3mm apex pins in the left 2nd metacarpal and midway in the radius.The triax monotube from a sterile wrist kit was placed over the pins.The surgeon reduced the fracture and tightened the bolts on the proximal pin clamp followed by the bolts on the distal pin clamp.The pin clamp on the distal pins was loosened to make further adjustments then all bolts were tightened again.Once the surgeon tried to loosen the flexion/extension control on the distal pin clamp, the bolt broke.A portion of the bolt remained in the pin clamp and another portion along with the head of the bolt was separated from the clamp.The 4 apex pins were removed and surgeon splinted the patient under x-ray.

• Brand Name: STERILE WRIST KIT MONOTUBE TRIAX 15MM X 200MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10349716
• Report Number: 0008031020-2020-02009
• Device Sequence Number: 14219202
• Product Code: JDW
• UDI-Device Identifier: 07613327093308
• UDI-Public: 07613327093308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: No Information
• Device Expiration Date: 11/30/2024
• Device Model Number: 5150-9-960
• Device Catalogue Number: 51509960
• Device Lot Number: D59459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR