MAUDE Adverse Event Report: STRYKER SPINE-FRANCE DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48080230
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the snake arm broke during the case and did not affect the patient outcome.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; upon manufacturing history review, device was found to be more than 6 years old.No relevant manufacturing issues were identified as all units met stryker specifications.Per email correspondence with the sales rep, the instrument has been used 50+ times.The surgical technique states that the snake arm should be properly reset and lubricated between uses.According to the general instrument instructions for use, instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery.The possible root causes of the reported product issue are - normal wear and tear of instruments and not lubricating the snake arm properly between uses as mentioned in the surgical technique.
Event or Problem Description
It was reported that the snake arm broke during the case and did not affect the patient outcome.

• Brand Name: DECOMPRESSION TUBE SNAKE ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5932247
• Report Number: 0009617544-2016-00357
• Device Sequence Number: 10966492
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: (01)07613327263909
• Combination Product (Y/N): N
• 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): 08/11/2016

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: 48080230
• Device Lot Number: 108602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1