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

Catalog Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the threads off the tap broke inside the patient l4 right pedicle.No adverse consequences to the patient and no surgical delay is reported.
Additional Manufacturer Narrative
The reported event was confirmed based on the visual inspection of returned product.The tap was inspected and it was confirmed that the tip was fractured.The fractured piece was not returned as it remains inside the patient.It was reported that awl was not used to prepare pedicle prior to tapping.Capa was opened to mitigate occurrences tip fracture and includes a design change that increases the thickness of the tap and updating the surgical technique requiring use of the awl prior to tapping has been implementing.The probable root cause of the reported event was determined to be design related - lower wall thickness: the wall thickness of the lower diameter taps are more susceptible to fracture or normal wear and tear of instruments.
Event or Problem Description
It is reported that the threads off the tap broke inside the patient l4 right pedicle.A surgical delay of 5 minute was reported.No adverse consequences to the patient.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7732531
• Report Number: 0009617544-2018-00185
• Device Sequence Number: 1619091
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 11/26/2018

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: 132071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1