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

Catalog Number 800804

Device Problems Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Event Description

It was reported that the tubing on the inserter got cut by the inserter while inserting the implant.

Manufacturer Narrative

Catalog# 800804.Lot# 06291501.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the inserter was returned for analysis and no issues were found therefore the reported event cannot be confirmed.The device was checked visually and functionally and it is fully functional.Conclusion: a plausible root cause could not be identified because the returned tl inserter was found to be fully functional.

Event Description

It was reported that the tubing on the inserter got cut by the inserter while inserting the implant.

• Brand Name: ACCULIF TL INSERTION HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5516430
• MDR Text Key: 41173074
• Report Number: 3004024955-2016-00033
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327067064
• UDI-Public: (01)07613327067064
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 800804
• Device Lot Number: 06291501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1