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

Model Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual inspection, the tip of the device was observed to be fractured.The fracture is located between the first thread and second thread from the of the distal end.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From es2 surgical technique: with dilator 2 in place, prepare the pedicle by placing the cannulated modular awl with selected handle over the k-wire or y-wire and insert into the pedicle with a twisting motion.Do not pinch the bifurcated tip of the y-wire with the distal tip of the awl.Hold the k-wire in position when removing the awl.Apply downward pressure to the y-wire when removing the awl to prevent unintentional removal.If necessary, use the cannulation of the slap hammer to impact the awl.The cannulated modular taps with selected handle are used to further prepare the screw pathway.The taps are designed to be used with either dilator 2 for taps 4.5mm-7.5mm in diameter or the tap sleeve for taps 4.5mm-8.5mm in diameter.The taps are laser etched with 5mm increments to help indicate the depth of the tap within the pedicle as well as to help determine proper screw length.Note: it is recommended that the awl is used to create a pilot hole prior to tapping.It is likely that the device fractured due to repeated use and excessive loading applied to the tip, as an awl was not used prior to tapping.
Event or Problem Description
It was reported that an es2 cannulated modular tap tip was found fractured during intra-op inspection.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.

• 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: 10722244
• Report Number: 0009617544-2020-00176
• Device Sequence Number: 11596651
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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 Model Number: 48280145
• Device Catalogue Number: 48280145
• Device Lot Number: 130742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1