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	02/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an inserter separated from the instrument.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the returned device was confirmed to have a fractured weld on the distal tip upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.Conclusion: the plausible root cause of the reported event cannot be identified.
Event or Problem Description
It was reported that the tip of an inserter separated from the instrument.

• 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: 5485512
• Report Number: 3004024955-2016-00022
• Device Sequence Number: 710986
• Product Code: LXH
• UDI-Device Identifier: 07613327105926
• UDI-Public: (01)07613327105926
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2016

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: 05061401-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• 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
• Patient Weight: 360