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

Model Number	58-30422
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2020
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
Primary procedure, left scaphoid.It was reported that the twinfix screw completely seated.Once the handle was set for screw compression, no compression occurred.When extraction was attempted, an all-blue portion of the screw came out and the rest stayed in.It is unknown how much (or if all) of the blue portion broke.It is unknown exactly when the screw broke (i.E.During implantation or during attempted compression).Surgeon pinned around the screw to address the fracture.Surgery was completed successfully with a surgical delay of approximately 5-10 minutes.

• 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: 10573204
• Report Number: 0008031020-2020-02262
• Device Sequence Number: 3073744
• Product Code: HRS
• UDI-Device Identifier: 04546540362124
• UDI-Public: 04546540362124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: Health Professional
• Device Model Number: 58-30422
• Device Catalogue Number: 58-30422
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR