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

Catalog Number	48281161
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	02/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, when the surgeon was using a tap, the surgeon found that the tip of the tap broke.Therefore the surgeon removed the broken tip of the tap.
Additional Manufacturer Narrative
Lot# 114396.Visual inspection; functional inspection; device history review; complaint history review; risk assessment; manufacturing files were reviewed and no anomalies were found.The instrument was found to be approximately 5 years old.The likely root cause is normal wear.
Event or Problem Description
It was reported that during the surgery, when the surgeon was using a tap, the surgeon found that the tip of the tap broke.Therefore the surgeon removed the broken tip of the tap.

• 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: 5495969
• Report Number: 0009617544-2016-00115
• Device Sequence Number: 445409
• Product Code: LXH
• UDI-Device Identifier: 07613327266504
• UDI-Public: (01)07613327266504
• 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): 02/17/2016

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: 114396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 65