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

Model Number	234-020-235
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
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.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: warping.Probable root cause: design, inadequate material selected for instrument, tip profile inadequate to support torque during use, tip profile does not fully interface with screw process, nonconforming raw material used, instrument not manufactured to print, incomplete material processing (ie heat treating) application, excessive or insufficient force used, screw inserted at an angle, incorrect size of screw for tunnel/graft, tap not used before insertion, driver not fully inserted into screw.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
Per investigation results, no pieces broke off of the driver, it was only twisted.This event description most likely indicates ¿driver tip twists or breaks off¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.Therefore making this event no longer reportable.
Additional Manufacturer Narrative
Please note that the initial report's type of reportable event was malfunction, per investigation results, no pieces broke off of the driver, it was only twisted.This event description most likely indicates ¿driver tip twists or breaks off¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.Therefore making this event no longer reportable.Alleged failure: during the procedure, in the act of placing the screws, there was the warping of the key, having to be replaced by another one, in order to end the procedure.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) screw inserted at an angle, 3) incorrect size of screw for tunnel/graft, 4) tap not used before insertion, or 5) driver not fully inserted into screw.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 11631595
• Report Number: 0002936485-2021-00204
• Device Sequence Number: 11525478
• Product Code: HXX
• UDI-Device Identifier: 04546540756350
• UDI-Public: 04546540756350
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/29/2021

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: 171127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 03/15/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/08/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR