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

Catalog Number	800044
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inserter tip was damaged and wouldn't allow the implant to fully seat.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: no relevant issues were identified in the manufacturing records.It was reported that the tip of the inserter was spinning freely during assembling with the implant.Surgical technique indicates to keep turning the blue rotator knob until the implant is connected tightly and two audible clicks are heard.The sales rep reported that he did not hear two clicks when turning the rotator knob what indicates the implant was not attached security.Conclusion: the plausible root cause cannot be identified conclusively as the device was not returned for evaluation.
Event or Problem Description
It was reported that the inserter tip was damaged and wouldn't allow the implant to fully seat.

• Brand Name: ACCULIF PL INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5784156
• Report Number: 3004024955-2016-00073
• Device Sequence Number: 18979530
• Product Code: LXH
• UDI-Device Identifier: 07613327105926
• UDI-Public: (01)07613327105926
• 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): 06/15/2016

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: 800044
• Device Lot Number: 0731140917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1