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

Catalog Number	800804
Medical Device Problem Codes	Mechanical Problem (1384); Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Per reported event; the inserter failed to lock.This provided an unsafe impaction environment.We had opened the implant and tubing, loaded the implant and upon loading discovered that the inserter didn't lock in place.We ended up using peek instead.Per additional communication, process to complete the surgery did not require a larger/additional incision on the patient and/or any other medical intervention that would be different had the cage been used as planned.Further communication with sales rep on (b)(6) 2017 indicated; the "unsafe impaction environment" is referring to surgeon indicating that the implant may damage the durra during insertion.Since implant was not able to lock, the implant would go back and forth during insertion.No adverse consequences reported.
Event or Problem Description
Per reported event; the inserter failed to lock.This provided an unsafe impaction environment.We had opened the implant and tubing, loaded the implant and upon loading discovered that the inserter didn't lock in place.We ended up using peek instead.Per additional communication, process to complete the surgery did not require a larger/additional incision on the patient and/or any other medical intervention that would be different had the cage been used as planned.Further communication with sales rep on (b)(6) 2017 indicated; the "unsafe impaction environment" is referring to surgeon indicating that the implant may damage the durra during insertion.Since implant was not able to lock, the implant would go back and forth during insertion.No adverse consequences reported.

• 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: 6802327
• Report Number: 3004024955-2017-00033
• Device Sequence Number: 1736110
• Product Code: LXH
• UDI-Device Identifier: 07613327105940
• UDI-Public: (01)07613327105940
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 160010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68