MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RELIANCE NERVE ROOT RETRACTOR MEDIUM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48360310
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; nerve root retractor broke when bent.
Additional Manufacturer Narrative
Risk assessment; lot number was not provided and product was not returned, therefore device inspection, device history review and complaint history review could not be performed.The possible root cases for the reported event are: user error - bending the instrument to retract the dura and normal wear and tear of instruments.
Event or Problem Description
It was reported that; nerve root retractor broke when bent.

• Brand Name: RELIANCE NERVE ROOT RETRACTOR MEDIUM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6219892
• Report Number: 0009617544-2017-00001
• Device Sequence Number: 1418655
• Product Code: LXH
• UDI-Device Identifier: 07613327268331
• UDI-Public: (01)07613327268331
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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: 48360310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR