MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS CANNULATED MODULAR TAP 7.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48281167
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip on the screwdriver for closed head screws sheared off from screwdriver upon insertion of screw into the bone.Screw and tip were left in place and used in construct.The tap was broken in bone upon tapping the bone.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: upon visual inspection, the tip was confirmed to be fractured.No manufacturing issues were discovered.Conclusion: the root cause of breakage was determined to be a result of cantilever forces generated during in-situ use.The higher hardness also participated to the breakage of instruments.
Event or Problem Description
It was reported that the tip on the screwdriver for closed head screws sheared off from screwdriver upon insertion of screw into the bone.Screw and tip were left in place and used in construct.The tap was broken in bone upon tapping the bone.

• Brand Name: MANTIS CANNULATED MODULAR TAP 7.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5499062
• Report Number: 0009617544-2016-00116
• Device Sequence Number: 1038066
• Product Code: LXH
• UDI-Device Identifier: 07613327266603
• UDI-Public: (01)07613327266603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2016

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: 48281167
• Device Lot Number: 070474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73