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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
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 the oem - biocomposites.
Event or Problem Description
It was reported that the device broke during the procedure and potentially remains in the patient.
Additional Manufacturer Narrative
The device manufacturer date is not known.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: in repair of acl, the screw breaks at the tunnel entry after the screw hamming.Investigation findings are: screw broke during surgery, technique or diameter of the tap likely contributed to the screw breakage.The suspected root causes are: technique used, tap diameter insufficient leading to strain on the screw.The corrective action: no corrective actions planned, surgery was completed successfully.The failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that the device broke during the procedure and potentially 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13195404
• Report Number: 0002936485-2022-00020
• Device Sequence Number: 11184083
• 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): 02/15/2022

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: BS210211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 87 KG