MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C 6MM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48328006
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the scrub tech tried to insert a cage into the inserter and it crossthreaded and snapped the metal thread.Scrub tech replaced with new and surgery was finished.No delay no adverse consequences.
Additional Manufacturer Narrative
Medical device: lot# 11d000.Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was inspected and the tip of the inserter was fractured off of the device.Per manufacturing history review the inserter was manufactured in january 2012.Conclusion: therefore the root cause of the reported event is crossthreading the cage and the inserter and/or normal wear and tear of the device.
Event or Problem Description
It was reported that: the scrub tech tried to insert a cage into the inserter and it crossthreaded and snapped the metal thread.Scrub tech replaced with new and surgery was finished.No delay no adverse consequences.

• Brand Name: ANCHOR C 6MM INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7012197
• Report Number: 0009617544-2017-00402
• Device Sequence Number: 16379753
• Product Code: LXH
• UDI-Device Identifier: 04546540679147
• UDI-Public: (01)04546540679147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 48328006
• Device Lot Number: 11D000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1