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	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that;the sales rep representative reported that the tip of the tap broke inside the patient during the procedure.The sales rep further reported that the k wire was inserted.There was a kink in the k wire which happened during the insertion process.The tap was placed down the k wire and the surgeon began tapping.When he removed the tap there was debris inside the patients bone, which he assumed to be the tip of the tap.The debris appeared to be in one piece.The surgeon did not attempt to get the tip of the tap out of the patient because the procedure was undertaken using a minimally invasive technique and removal of the tip would have made the procedure more invasive.The surgeon reported that he was not unduly concerned about the unintended metal in the patient.The sales representative was in the case.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the reported event was confirmed via visual inspection.Manufacturing records were reviewed and no relevant issues were found.Conclusion: the probable root causes of this event are user error - awl not being used to prepare the pedicle; or normal wear and tear of instruments.
Event or Problem Description
It was reported that the sales rep representative reported that the tip of the tap broke inside the patient during the procedure.The sales rep further reported that the k wire was inserted.There was a kink in the k wire which happened during the insertion process.The tap was placed down the k wire and the surgeon began tapping.When he removed the tap there was debris inside the patients bone, which he assumed to be the tip of the tap.The debris appeared to be in one piece.The surgeon did not attempt to get the tip of the tap out of the patient because the procedure was undertaken using a minimally invasive technique and removal of the tip would have made the procedure more invasive.The surgeon reported that he was not unduly concerned about the unintended metal in the patient.The sales representative was in the case.

• 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: 6402161
• Report Number: 0009617544-2017-00095
• Device Sequence Number: 10931259
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 05/17/2017

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 Catalogue Number: 48280145
• Device Lot Number: 151527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1