MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	656414
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2020
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
As reported: "dr.Was tightening the screw into the plate by hand and the head of the screw cleanly twisted off of the shaft" surgical delay - 10 minutes.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10819588
• Report Number: 0008031020-2020-02441
• Device Sequence Number: 16428543
• Product Code: HWC
• UDI-Device Identifier: 07613327068894
• UDI-Public: 07613327068894
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• 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): 11/10/2020

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: 656414
• Device Catalogue Number: 656414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1