MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY 4.5MM CANNULATED TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2210XLP
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the surgeon used the tap(4.5mm).During using the tap 4.5mm, the surgeon found that the tip of tap broke.The surgeon could not remove the broken tip of tap from the patient bone.There was a mistake in the catalog number in this case, and sales rep was checking it.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.The most likely cause of the customer reported event is eventual wear of the device leading to fracture.
Event or Problem Description
It was reported that; during surgery, the surgeon used the tap(4.5mm).During using the tap 4.5mm, the surgeon found that the tip of tap broke.The surgeon could not remove the broken tip of tap from the patient bone.There was a mistake in the catalog number in this case, and sales rep was checking it.

• Brand Name: SPECIALTY 4.5MM CANNULATED TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5912536
• Report Number: 3004024955-2016-00080
• Device Sequence Number: 391983
• Product Code: LXH
• UDI-Device Identifier: 07613327141900
• UDI-Public: (01)07613327141900
• 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): 02/24/2017

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: IS2210XLP
• Device Lot Number: MT9E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1