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

Catalog Number	800044
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a distal end of the inserter broke off.The surgeon had inserted a cage successfully on the patient's right side.He was then inserting a second cage on the patient's left side and observed under flouro that the implant was to anterior.So he requested a slap hammer.Upon using the slap hammer a couple of strikes, the inserter had a lot of slack and it was concerned the implant had come loose.Upon flouro observation, the implant was still attached and the surgeon was able to get the implant moved to the ideal location.The implant was than expanded successfully to the ideal height.Upon removal of the inserter it was observed that the distal end of the inserter had broken off.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a fractured tip upon visual inspection of the returned device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the plausible root cause is normal wear and tear of the instrument.
Event or Problem Description
It was reported that a distal end of the inserter broke off.The surgeon had inserted a cage successfully on the patient's right side.He was then inserting a second cage on the patient's left side and observed under flouro that the implant was to anterior.So he requested a slap hammer.Upon using the slap hammer a couple of strikes, the inserter had a lot of slack and it was concerned the implant had come loose.Upon flouro observation, the implant was still attached and the surgeon was able to get the implant moved to the ideal location.The implant was than expanded successfully to the ideal height.Upon removal of the inserter it was observed that the distal end of the inserter had broken off.

• 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: 5567922
• Report Number: 3004024955-2016-00041
• Device Sequence Number: 13517073
• Product Code: LXH
• UDI-Device Identifier: 07613327105926
• UDI-Public: (01)07613327105926
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2016

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: 05061401-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2016
• Supplement Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 122