MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during use of the spinal system, while using the 4.5mm tap over a nitinol k-wire, the tip of the tap broke off into the vertebral body patient.The missing fragment was not recovered and left inside the patient.
Additional Manufacturer Narrative
Weight: (b)(6).The customer reported event was confirmed via visual inspection.The returned device was inspected and it was found that the tap tip was fractured from the device.The fractured piece was not returned.Material analysis was performed and the tap tip was found to have fractured in torsional ductile overload.The hardness and elemental constituents were consistent with the specifications on the print.No material or manufacturing defects were found.Manufacturing history was reviewed and no issues were identified.A root cause of the event is too much torsional force applied during pedicle preparation.Additionally the surgical technique recommends to use awl for pedicle preparation before tapping.Per email correspondence, awl was not used.
Event or Problem Description
It was reported that; during use of the spinal system, while using the 4.5mm tap over a nitinol k-wire, the tip of the tap broke off into the vertebral body patient.The missing fragment was not recovered and left inside the patient.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7149240
• Report Number: 0009617544-2017-00441
• Device Sequence Number: 1497654
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 48280145
• Device Lot Number: 153234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/03/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 65