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

Model Number	48281161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; treatment for l2 fracture.The l1 left vertebral bone was hard and could not insert the tap completely into l1, but inserted the screw and completed the procedure after that it was found the tip of tap was fractured after procedure.
Additional Manufacturer Narrative
The customer reported event of tap tip fracture was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met stryker specifications.The plausible root cause of the event is determined to be multifactorial.Contributing factors are: excessive torsional force applied to the device, not using awl to prepare the hole, age of the device.
Event or Problem Description
It was reported that; treatment for l2 fracture.The l1 left vertebral bone was hard and could not insert the tap completely into l1.But inserted the screw and complete the procedure.After that it was found the tip of tap was fractured after procedure.

• 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: 6722985
• Report Number: 0009617544-2017-00290
• Device Sequence Number: 16454603
• 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): 09/27/2017

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 Model Number: 48281161
• Device Catalogue Number: 48281161
• Device Lot Number: B81412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 47