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	05/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting the cage, inserter was pressed against screw post of the retractor and as a result the casing of the inserter where the tubing engages with the handle broke off.
Additional Manufacturer Narrative
Lot# 12181420-7.Method: visual inspection; device history review; complaint history review; risk assessment; results: the sales rep reported that the acculif tl inserter was pressed against screw post of pbr retractor and as a result the weld that connects the locking plate to the insertion handle broke off.Saline was leaking from the broken area.Conclusion: a plausible root cause of the reported event is most likely user related.
Event or Problem Description
It was reported that while inserting the cage, inserter was pressed against screw post of the retractor and as a result the casing of the inserter where the tubing engages with the handle broke off.

• 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: 5676088
• Report Number: 3004024955-2016-00055
• Device Sequence Number: 189931
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/03/2016

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: 12181420-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 08/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1