MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE PITUITARY RONGEUR STR 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48360100
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pituitary was being used when the back trigger piece broke when the surgeon went to squeeze the instruments.
Additional Manufacturer Narrative
No relevant manufacturing issues found upon device history review.The age of the device was found to be 8 years old.Conclusion: the probable root cause of this event is normal wear and tear of instruments.
Event or Problem Description
It was reported that the pituitary was being used when the back trigger piece broke when the surgeon went to squeeze the instruments.

• Brand Name: RELIANCE PITUITARY RONGEUR STR 4 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: 6440686
• Report Number: 0009617544-2017-00115
• Device Sequence Number: 18987966
• Product Code: LXH
• UDI-Device Identifier: 07613327268300
• UDI-Public: (01)07613327268300
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/06/2017

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: 48360100
• Device Lot Number: 080532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1