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

Catalog Number	800804
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter was damaged during the surgery.The cage would not expand and the inserter was leaking in the disc space.The cage was removed and peek spacer was used.Upon inspection, it was apparent that the tubing had gotten caught in the articulating joint of the inserter and subsequently torn.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the inserter was returned for analysis and no issues were found therefore the reported event cannot be confirmed.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: a plausible root cause could not be identified because the returned inserter was found to be fully functional.
Event or Problem Description
It was reported that the inserter was damaged during the surgery.The cage would not expand and the inserter was leaking in the disc space.The cage was removed and peek spacer was used.Upon inspection, it was apparent that the tubing had gotten caught in the articulating joint of the inserter and subsequently torn.

• 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: 5531899
• Report Number: 3004024955-2016-00036
• Device Sequence Number: 16209578
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• 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): 03/03/2016

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: 06291501-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1