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	03/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that while taping with 4.5 diameter cannulated tap, a 3-4mm piece of the tip of the tap broke of and was lodged in the bone of the pedicle.It took about 45 minutes for surgeon to retrieve and remove broken tip.No adverse consequences reported.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The device was inspected and it was found that the tip was fractured.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be more than 5 years old.Corrective action was opened to mitigate similar occurrences 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.The most probable root cause of the reported event is design related.Es2 taps were identified to have 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 while taping with 4.5 diameter cannulated tap, a 3-4mm piece of the tip of the tap broke of and was lodged in the bone of the pedicle.It took about 45 minutes for surgeon to retrieve and remove broken tip.No adverse consequences reported.

• 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: 7455683
• Report Number: 0009617544-2018-00090
• Device Sequence Number: 1055937
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 06/22/2018

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: Health Professional
• Device Catalogue Number: 48280145
• Device Lot Number: 126396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1