MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 8MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-162
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
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 and pieces were potentially remaining in the patient.
Event or Problem Description
It was reported that the screw broke and pieces were potentially remaining in the patient.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: loose, does not fit well.According to biocomposites: investigation findings are: the use of the tarraja is considered an improper use of the medical device.Instructions for use must be understood and followed to allow the medical device to operate and function as desired/designed.The use of a tarraja weakened the screw, allowing it to break, leading to the loss of torque feeling.The suspected root causes are: improper use of the device, instructions for use not followed.The device manufacture date is not known.

• Brand Name: PKG. 8MM 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: 11971467
• Report Number: 0002936485-2021-00308
• Device Sequence Number: 1376189
• Product Code: HWC
• UDI-Device Identifier: 15060155710256
• UDI-Public: 15060155710256
• 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): 07/29/2021

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: 234-010-162
• Device Catalogue Number: 234-010-162
• Device Lot Number: BS200306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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: 24 YR
• Patient Weight: 73