MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS CANNULATED MODULAR TAP 4.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48281161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was preparing a pedicle to implant a screw when the tip of the tap broke.The patient had extremely hard bone at this level.The surgeon tried to use a larger tap but the broken fragment was in the pedicle which prevented from implanting a screw.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the tip breakage was confirmed upon visual inspection of the device.Manufacturing files were reviewed and no anomalies were found.Conclusion: the instrument was reported to have been used about 20 times, however the bone quality of the patient was unknown so the root cause is not determined and multifactorial.
Event or Problem Description
It was reported that the surgeon was preparing a pedicle to implant a screw when the tip of the tap broke.The patient had extremely hard bone at this level.The surgeon tried to use a larger tap but the broken fragment was in the pedicle which prevented from implanting a screw.

• Brand Name: MANTIS CANNULATED MODULAR TAP 4.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5514620
• Report Number: 0009617544-2016-00124
• Device Sequence Number: 351988
• Product Code: LXH
• UDI-Device Identifier: 07613327266504
• UDI-Public: (01)07613327266504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2016

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: 48281161
• Device Lot Number: B86923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1