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

Catalog Number	234-020-235
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the biosteon screw driver broke during procedure.Additional information confirmed all pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
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.Alleged failure: broke.Probable root cause: design improper packaging design.Product design insufficient to withstand transport process.Product manufactured out of specification (eg thin walls).Improper assembly application.Rough handling during shipping.The device manufacturer date is not known.
Event or Problem Description
It was reported that the biosteon screw driver broke during procedure.Additional information confirmed all pieces were retrieved and the procedure was completed successfully.

• 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: 7881204
• Report Number: 0002936485-2018-00607
• Device Sequence Number: 19514427
• 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): 11/30/2018

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 Catalogue Number: 234-020-235
• Device Lot Number: 151132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 76