MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48480111
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; when trying to remove the inserter from the already final fixed implantation construct, the lower part of the inserter dissolved.The cut was extended by 1cm and the instrument could be removed completely.Replacement was available and the procedure could be completed successfully.Sales rep was present during surgery.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was inspected and the tip was found to be deformed.No relevant manufacturing issues found upon device history review.Based on the risk file and the age of the device, possible root causes of the reported events are: "too much rotational force applied during rod insertion or removal" and "material wear and tear of instruments due to extended use".
Event or Problem Description
It was reported that; when trying to remove the inserter from the already final fixed implantation construct, the lower part of the inserter dissolved.The cut was extended by 1cm and the instrument could be removed completely.Replacement was available and the procedure could be completed successfully.Sales rep was present during surgery.

• Brand Name: MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6060460
• Report Number: 0009617544-2016-00429
• Device Sequence Number: 10847455
• Product Code: LXH
• UDI-Device Identifier: 07613327270815
• UDI-Public: (01)07613327270815
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48480111
• Device Lot Number: 10H216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 90