MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C TAP-DRILL-12MM SQUARE AWL-PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328812
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; despite being warned (after going over technique guide), the doctor over angled both drill and drill bit.Update (18-may-2016): device fracture.Delay, had to use another product to complete the procedure.Took out all of the implants and used another.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the stg warns against excessively bending the tap-drill square awl-probe past 35 degrees.It was reported that the surgeon bent the shaft beyond 35 degrees during this procedure to clear the chin and that the instrument was used an unknown amount of times.Conclusion: the plausible root cause of the reported event is therefore bending the shaft beyond the recommended angle per the stg.
Event or Problem Description
It was reported that; despite being warned (after going over technique guide) the doctor over angled both drill and drill bit.Update (18-may-2016): device fracture.Delay, had to use another product to complete the procedure.Took out all of the implants and used another.

• Brand Name: ANCHOR C TAP-DRILL-12MM SQUARE AWL-PROBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5691230
• Report Number: 0009617544-2016-00213
• Device Sequence Number: 336981
• Product Code: LXH
• UDI-Device Identifier: 07613327126280
• UDI-Public: (01)07613327126280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 05/06/2016

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: No Information
• Device Catalogue Number: 48328812
• Device Lot Number: 125443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 08/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1