MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL INSERTER GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; inserter guide inner shaft broke during surgery.It broke when the shaft was being inserted into implant.
Additional Manufacturer Narrative
Lot# 143459.Method: visual inspection, complaint history review, risk assesment; result: the customer reported event of an inner shaft tip fracture was confirmed via visual insp.It was reported that "the inserter was impacted due to too much torque." previous materials analysis results indicated that the guide rod fractured through bending overload.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be user's impact overloading.
Event or Problem Description
It was reported that; inserter guide inner shaft broke during surgery.It broke when the shaft was being inserted into implant.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5673057
• Report Number: 0009617544-2016-00201
• Device Sequence Number: 18876776
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: (01)07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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: 48921100
• Device Lot Number: 143459
• 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: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1