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

Model Number	234-010-161
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/13/2020
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.
Event or Problem Description
It was reported that the screw broke and potentially remains in the patient.
Event or Problem Description
It was reported that the screw broke and potentially remains in the patient.
Additional Manufacturer Narrative
Alleged failure: screw broke.According to biocomposites: "customer complaint: complainant has stated "during the surgical procedure, when placing the screw at the correct angle of the key, and without excessive force, it broke." investigation findings are: screw broke due to technique used.Warnings and precautions, including prevention of screw breakage are stated in the instructions for use.No medical intervention was required.The suspected root causes are tapped depth and diameter insufficient causing strain on the device during implantation." the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• 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: 10154084
• Report Number: 0002936485-2020-00236
• Device Sequence Number: 2318962
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: BS190701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: 39 YR