MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE PITUITARY RONGEUR 2 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48360134
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; pituitary broke while using during tlif.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: upon visual inspection of the returned device, it was found that the shaft would disengage partly from the handle.No relevant manufacturing issues found upon device history review.Conclusion: the probable root cause of this event is normal wear and tear of instruments.
Event or Problem Description
It was reported that; pituitary broke while using during tlif.

• Brand Name: RELIANCE PITUITARY RONGEUR 2 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6254357
• Report Number: 0009617544-2017-00014
• Device Sequence Number: 1027257
• Product Code: LXH
• UDI-Device Identifier: 07613327268287
• UDI-Public: (01)07613327268287
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/24/2017

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: 48360134
• Device Lot Number: 117133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1