MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 7MM X 28MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-164
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
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.
Event or Problem Description
It was reported that the screw broke during the procedure and a piece potentially 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: customer contacted stryker france per unit and reported the following issue: "the screw has broken during installation (dr mezghani, clinic orangerie).See picture.Patient neither clinically suspect nor affected.Non-risky procedure".Investigation findings are: information provided was too limited to fulfil a detailed investigation.No image was provided.Warnings and precautions, including prevention of screw breakages are stated in the instructions for use.No medical intervention was required.The suspected root causes are unable to confirm.The corrective action no corrective actions planned - surgery completed successfully." the failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that the screw broke during the procedure and a piece potentially remained in the patient.

• Brand Name: PKG. 7MM 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
• 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: 12921048
• Report Number: 0002936485-2021-00686
• Device Sequence Number: 17445011
• Product Code: HWC
• UDI-Device Identifier: 15060155710270
• UDI-Public: 15060155710270
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/14/2022

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: 234-010-164
• Device Catalogue Number: 234-010-164
• Device Lot Number: BS210507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/14/2022
• 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 Sex: Unknown