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

Model Number	48280155
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap sheared off intra-operatively.The tip was not able to be retrieved and was left in the patient.Surgery was successfully completed with a back up instrument and no delay.
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap sheared off intra-operatively.The tip was not able to be retrieved and was left in the patient.Surgery was successfully completed with a back up instrument and no delay.
Additional Manufacturer Narrative
The device was returned for visual inspection, which indicates the tip has fractured at the chamfer between the third and fourth thread from the distal tip.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Upon correspondence with the sales representative, it was stated that an awl was not used and the screw hole was not prepared before tapping.Per the es2 surgical technique " it is recommended that the awl is used to create a pilot hole prior to tapping." (page 16).It was also stated that the device has been used 120-150 times.This device was manufactured in 2012 and is in scope of a capa initiated in october 2015 to update the surgical technique to include the recommendation to use as awl prior to tapping, as indicated above as well as increase wall thickness.The most likely root cause of the reported event is that the device fractured due to repeated use and excessive loading applied to the tip, as an awl was not used prior to tapping, as indicated in the product labeling.

• 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: 10221920
• Report Number: 0009617544-2020-00114
• Device Sequence Number: 535824
• Product Code: ETN
• UDI-Device Identifier: 04546540710420
• UDI-Public: 04546540710420
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140400
• 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): 09/29/2020

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: 48280155
• Device Catalogue Number: 48280155
• Device Lot Number: 126397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1