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

Catalog Number	48280145
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery the tip of the tap broke when it was used to l4 right side.The tip is remained to the patient.The broken part remained in l4.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were identified as all units met stryker specifications.The tap was inspected and it was found that the tip was fractured.Conclusion: the probable root causes of this event are user error.
Event or Problem Description
It was reported that; during surgery the tip of the tap broke when it was used to l4 right side.The tip is remained to the patient.The broken part remained in l4.

• 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: 6537200
• Report Number: 0009617544-2017-00184
• Device Sequence Number: 75120
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• 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): 08/23/2017

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: 153234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR