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	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of device is unknown.
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap broke off in the l5 pedicle intra-operatively.The broken piece was left in due to the patient's hard bone.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained and the device was not returned.Per surgical technique: once the k-wire is inserted, remove the k-wire guide tube, if used, and the outer shaft of the needle.Take care to hold the k-wire in position when removing the outer shaft of the needle.Remove dilator 1 after inserting and fully seating dilator 2.Take care to maintain the position of the k-wire or y-wire within the pedicle when removing dilator 1.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.It is recommended that the awl is used to create a pilot hole prior to tapping.Do not pinch the bifurcated tip of the y-wire with the distal tip of the tap.Hold the k-wire in position when removing the tap.As the awl or tap advances into the pedicle, the proximal end will move relative to the markings on the k-wire.If this does not occur during insertion, the procedure should be stopped and imaging should be used to verify the position of the k-wire in relation to the awl or tap.Cantilevering the awl and taps while in the pedicle may damage the k-wire.It was reported that due to the patient hard bone, the tapping process was "more physically demanding but not excessive".The tap was not being impacted or malleted at the time the incident occurred.Most likely cause of reported event determined to be lack of awling and patient hard bone.
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap broke off in the l5 pedicle intra-operatively.The broken piece was left in due to the patient's hard bone.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were 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: 10971265
• Report Number: 0009617544-2020-00208
• Device Sequence Number: 13629049
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• 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): 03/26/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1