MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	800804
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter sliced tubing and lost pressure.Therefore, the implant did not expand.Slicing happened when implant was rotated outside the patient body.
Additional Manufacturer Narrative
Lot# 06291501.Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the tl inserter was not received by the complaints department.Conclusion: one of the possible factors for tube set being cut is user applying excessive force to the inserter during implant positioning.
Event or Problem Description
It was reported that the inserter sliced tubing and lost pressure.Therefore, the implant did not expand.Slicing happened when implant was rotated outside the patient body.

• Brand Name: ACCULIF TL INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5432169
• Report Number: 3004024955-2016-00014
• Device Sequence Number: 493816
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: 07613327105940
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/19/2016

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: 800804
• Device Lot Number: 06291501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1