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	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
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 and part of it remains implanted in the patient.
Event or Problem Description
It was reported that the screw broke and part of it remains implanted in the patient.
Additional Manufacturer Narrative
Alleged failure: screw broken, half remained in patient.According to biocomposites: customer complaint: in the acl procedure, drilling is done with a 9mm drill bit, the screw is passed and the biosteon screw is passed, and when the screw is being placed, the screw is billed without resistance or generating a noise.Investigation findings are: complaint could not be investigated as the initial complaint text was difficult to understand.Quality assurance coordinator (lr) requested a better translation on the complaint text to better investigate the complaint from stryker.Stryker confirmed they will be closing the complaint on their end and will not pursue the complaint.The suspected root causes are: n/a.The corrective action: no corrective action as investigation was not performed.The preventive action: n/a.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known h3 other text : 81.

• 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: 10759931
• Report Number: 0002936485-2020-00443
• Device Sequence Number: 19629441
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: B5190908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 31 YR
• Patient Weight: 80