MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE RASP HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48361235
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; trial handle broke off in alif trial.
Additional Manufacturer Narrative
Lot# 134002.Method: visual inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified for the reported lot.The device was inspected and it was found that the tip of the slide rasp handle was fractured.Conclusion: the age of the device (more than 3 years) concludes plausible root cause to be "normal wear based on age and extensive use of the device.".
Event or Problem Description
It was reported that; trial handle broke off in alif trial.

• Brand Name: SLIDE RASP HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6080558
• Report Number: 0009617544-2016-00442
• Device Sequence Number: 13853618
• Product Code: LXH
• UDI-Device Identifier: 07613327269116
• UDI-Public: (01)07613327269116
• Combination Product (Y/N): N
• 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): 01/13/2017

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: 48361235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1