MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID RETAINING COLLET SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48511815
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that; the tip of the screwdriver broke during surgery.Replacement was available.Nothing felt in to patient site.
Additional Manufacturer Narrative
The reported device was confirmed visually to have the distal tip with a missing pin that held the collet screwdriver ring to the tip.Manufacturing files were reviewed and no manufacturing issues were found for this lot number.Manufacturing review revealed that the instrument was manufactured and released in 2010.The likely root cause is normal wear of the instrument.
Event or Problem Description
It is reported that; the tip of the screwdriver broke during surgery.Replacement was available.Nothing felt in to patient site.

• Brand Name: REFLEX HYBRID RETAINING COLLET SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5829176
• Report Number: 0009617544-2016-00310
• Device Sequence Number: 598582
• Product Code: LXH
• UDI-Device Identifier: 07613327270938
• UDI-Public: (01)07613327270938
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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: 48511815
• Device Lot Number: 09A998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2016
• Supplement Report FDA Received Date: 10/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1