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

Catalog Number	IS2210XLP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, the tip of the tap instrument broke off and was noticed post-operatively.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The event resulted in a no surgical delay.The device was confirmed to have the tip fractured off.Tap tip was not retrieved.The fractured piece was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the tap was used less than 10 cases and he had it for 1 year.Inserted at a normal angle and the pedicle probe was used to prep the hole.Tap was not impacted and the patient had normal bone quality.The tap fracture was not noticed until after the case during putting the kit back together.No way for rep to confirm if it was broken before, during, or after the case.Material analysis was performed and the tip of the tap was found to have fractured in a mixed mode of ductile and cleavage overload due to an applied cantilever force.The measured hardness and observed elemental constituents were consistent with the print.No material or manufacturing defects were found.Conclusion: as it is unknown when the tip fractured, a definite root cause cannot be determined.As material analysis found that the tap fractured due to an applied cantilever force, it is possible the tap fractured during rough handling during cleaning/sterilization, such as getting caught on or in-between a tray.
Event or Problem Description
During surgery, the tip of the tap instrument broke off and was noticed post-operatively.No adverse consequences to the patient were reported.

• 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: 7669804
• Report Number: 3004024955-2018-00039
• Device Sequence Number: 19178467
• Product Code: LXH
• UDI-Device Identifier: 07613327141900
• UDI-Public: 07613327141900
• Combination Product (Y/N): N
• 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): 11/19/2018

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: IS2210XLP
• Device Lot Number: AP12E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1