MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 23/28/35MM BIOSTEON SCREW DRIVER; SCREWDRIVER

Model Number	234-020-235
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
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.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: broken.Probable root cause: design: improper packaging design, product design insufficient to withstand transport.Process: product manufactured out of specification -improper assembly.Application: rough handling during shipping.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.

• Brand Name: PKG., 23/28/35MM BIOSTEON SCREW DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10597296
• Report Number: 0002936485-2020-00395
• Device Sequence Number: 2410108
• Product Code: HXX
• UDI-Device Identifier: 04546540756350
• UDI-Public: 04546540756350
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 234-020-235
• Device Catalogue Number: 234-020-235
• Device Lot Number: 155880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1