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

Catalog Number	48360100
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during lumbar fusion surgery,the bottom of the pituitary rongeur is fractured.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was 6 years old at the time of the reported event.The most likely cause of the reported event was determined to be normal wear based on the age of the device.
Event or Problem Description
It was reported that during lumbar fusion surgery,the bottom of the pituitary rongeur is fractured.

• 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: 6485381
• Report Number: 0009617544-2017-00140
• Device Sequence Number: 11033459
• Product Code: LXH
• UDI-Device Identifier: 07613327268300
• UDI-Public: (01)07613327268300
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 113476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1