MAUDE Adverse Event Report: ARTHREX, INC. SUTURE CUTTER, OPEN ENDED, LEFT NOTCH; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/07/2022, it was reported by an arthrex employee via sems that an ar-11794l suture cutter had an issue.During a rotator cuff repair surgery on (b)(6) 2022, the suture cutter was broken suddenly, it could not cut anymore.The piece broke off inside the patient, the fragment was retrieved from the patient and there was no harm to the patient.The surgeon used another new product with the same type and lot number to complete the procedure successfully, no second operation was needed.This was discovered during use with no impact to the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the pin to hold the moving jaw is missing and one side of the cutter is broken.The broken piece was not returned for investigation.The cause of this remains undetermined.

• Brand Name: SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15484223
• Report Number: 1220246-2022-05533
• Device Sequence Number: 15425663
• Product Code: MDM
• UDI-Device Identifier: 00888867003590
• UDI-Public: 00888867003590
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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
• Device Model Number: SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
• Device Catalogue Number: AR-11794L
• Device Lot Number: 10239176
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown