MAUDE Adverse Event Report: STRYKER SPINE-US ES2 CANNULATED MODULAR TAP; STIMULATOR, NERVE

Catalog Number	48280155
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon tapped the pedicle in preparation for a screw, the thread of the tap pulled away from the base, surgical delay of a few seconds to switch out the 5.5 mm tap for a 4.5 mm.No adverse consequence to the patient.
Additional Manufacturer Narrative
Manufacturing records were reviewed and no relevant issues were found; the device was manufactured to specifications.The tap was inspected and it was confirmed that the tip was fractured.A corrective action was opened to mitigate occurrences of the es2 4.5 mm tap tip fractures.The most probable root cause of the reported event is design related.The wall thickness of the smaller diameter es2 taps are more susceptible to fracture and normal wear and tear of instruments.A design change was put into place which increases the thickness of the tap and the surgical technique was updated to require use of the awl prior to tapping.
Event or Problem Description
It was reported that when the surgeon tapped the pedicle in preparation for a screw, the thread of the tap pulled away from the base, surgical delay of a few seconds to switch out the 5.5mm tap for a 4.5mm.No adverse consequence to the patient.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8802658
• Report Number: 0009617544-2019-00088
• Device Sequence Number: 320387
• Product Code: ETN
• UDI-Device Identifier: 04546540710420
• UDI-Public: 04546540710420
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140400
• 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): 09/27/2019

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: 48280155
• Device Lot Number: 140710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1