MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 7MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-161
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of oem biocomposites.
Event or Problem Description
It was reported that the screw broke during the procedure and the tip remains in the patient.
Additional Manufacturer Narrative
The device manufacturer date is not known.The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: screw broke.According to biocomposites: "investigation findings are: the peak (tip) of the screw was likely rubbing against the bone during the insertion technique and movement, leading to a split device.The suspected root causes are forward force (insertion force) may have contributed to the peak of the screw to be split.The sides of the screw were not biting to the bone leading to a "loss of torque" feeling." the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the screw broke during the procedure and the tip remains in the patient.

• Brand Name: PKG. 7MM X 23MM STRYKER BIOSTEON SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11175303
• Report Number: 0002936485-2021-00034
• Device Sequence Number: 2350189
• Product Code: HWC
• UDI-Device Identifier: 15060155710249
• UDI-Public: 15060155710249
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K003641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 234-010-161
• Device Catalogue Number: 234-010-161
• Device Lot Number: BS200102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Weight: 166