MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 11MM X 35MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-179
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw broke during the procedure and remained in the patient.
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.This report was filed on behalf of the legal manufacturer - biocomposites.
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: "in the surgical act, when trying to insert the 11x35mm screw, it broke inside the patient." investigation findings are: screw broke during surgery, technique likely attributed to breakage.The suspected root causes are: improper technique, tap diameter insufficient leading to strain on the screw.The corrective action: no corrective action planned, surgery was completed successfully.The manufacture date is not known.The failure mode will be monitored for future reoccurrence.H3 other text: 81.
Event or Problem Description
It was reported that the screw broke during the procedure and remained in the patient.

• Brand Name: PKG, 11MM X 35MM 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: 13192575
• Report Number: 0002936485-2022-00018
• Device Sequence Number: 1580985
• Product Code: HWC
• UDI-Device Identifier: 15060155710331
• UDI-Public: 15060155710331
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 234-010-179
• Device Catalogue Number: 234-010-179
• Device Lot Number: BS190608
• 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 Sex: Male