MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 8MM X 28MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-165
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
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 the oem biocomposites.
Event or Problem Description
It was reported that the screw broke during the procedure and remained in the patient.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.This investigation will be closed based on probable root cause.Alleged failure: screw broke.Customer complaint: "biosteon screw was broken in acl surgery.Investigation findings are: surgery was completed successfully with an equivalent device and the patient had no negative consequences.Feedback was received via julio r.Of stryker.The screw has been returned to the warehouse for investigation and any additional findings from inspection will be added to this complaint investigation.The patient was being treated with a hamstring graft, the additional instrumentation being using was an 8mm stryker versitomic cannulated reamer used in tibia and our stryker complete acl instrumentation.No additional observations were made, claiming excessive force was not used.Despite the provision of additional information, this was still limited in aiding the investigation.Warnings and precautions, including prevention of screw breakages are stated in the instructions for use.Information provided was too limited to fulfil a detailed investigation.The suspected root causes are: unable to confirm.The corrective action: none required.Surgery was completed successfully.The preventive action: n/a" the manufactures date is not known.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the screw broke during the procedure and remained in the patient.

• Brand Name: PKG, 8MM X 28MM 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: 12388947
• Report Number: 0002936485-2021-00477
• Device Sequence Number: 3602329
• Product Code: HWC
• UDI-Device Identifier: 15060155710287
• UDI-Public: 15060155710287
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K003641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 234-010-165
• Device Catalogue Number: 234-010-165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/11/2021
• 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