MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 9MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
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 potentially remains in the patient.
Event or Problem Description
It was reported that the screw broke during the procedure and potentially remains 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.Customer complaint/comment: (b)(6) (customer) reported that "we inform you that several incidents (3) have occurred with the device : interference bioabsorbable screw 9x23mm biosteon reference (b)(4) (lot bs211120) users observed a crushing of the screw thread during implantation, then a breakage of the screw.Investigation findings are: minimal information has been provided.No indication found that biosteon screw was nonconforming.The suspected root causes are unable to determine without further information from clinician or images of product.The corrective action no corrective actions planned; surgery was completed successfully.The preventive action no preventive actions planned; surgery was completed successfully.Manufacture date is not known.H3 other text : 81.

• Brand Name: PKG. 9MM 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: 14003984
• Report Number: 0002936485-2022-00159
• Device Sequence Number: 17228319
• Product Code: HWC
• UDI-Device Identifier: 15060155710263
• UDI-Public: 15060155710263
• 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: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: 234-010-163
• Device Catalogue Number: 234-010-163
• Device Lot Number: BS211120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/30/2022
• 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