MAUDE Adverse Event Report: STRYKER GMBH CANNULATED COMPRESSION SCREW; PLATE, FIXATION, BONE

Model Number	58-30424
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that in using the twinfix screw to reduce a left scaphoid fracture, the surgeon felt the screw may have been driven too far.When the surgeon attempted to back the screw up, the proximal (blue) portion was pulling away from the distal (gold) portion.The proximal portion was removed and the distal portion driven through and removed from the distal side.A second screw was implanted and the procedure was completed successfully with a 1-hour surgical delay.

• Brand Name: CANNULATED COMPRESSION SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11636100
• Report Number: 0008031020-2021-00141
• Device Sequence Number: 19753728
• Product Code: HRS
• UDI-Device Identifier: 04546540362148
• UDI-Public: 04546540362148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K013775
• 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
• Report Date (Section B): 04/08/2021

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 Model Number: 58-30424
• Device Catalogue Number: 58-30424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR