MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG LARYNGEAL ELECTRODE SELECT UNIV CABLE; SURGICAL NERVE STIMULATOR/LOCATOR

Model Number	5140-530-866
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was damaged and could not provide accurate connection during a surgical procedure at the user facility.This condition, in which the electrical circuit is incomplete, may result in the loss of nerve monitoring recording function, posing increased risk of transection of a nerve.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.
Event or Problem Description
It was reported the device was damaged and could not provide accurate connection during a surgical procedure at the user facility.This condition, in which the electrical circuit is incomplete, may result in the loss of nerve monitoring recording function, posing increased risk of transection of a nerve.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Additional information: h4-manufacture date follow-up report submitted to document device evaluation results.

• Brand Name: LARYNGEAL ELECTRODE SELECT UNIV CABLE
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 8760478
• Report Number: 0001811755-2019-02209
• Device Sequence Number: 1541572
• Product Code: ETN
• UDI-Device Identifier: 07613327298086
• UDI-Public: 07613327298086
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K091874
• 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): 12/11/2020

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: 5140-530-866
• Device Catalogue Number: 5140-530-866
• Device Lot Number: 18F013R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1