MAUDE Adverse Event Report: ARTHREX, INC. SUTURE PASSING WIRE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURE PASSING WIRE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2021, it was reported by a arthrex employee via e-mail that a ar-1255-18 suture passing wire broke.This occurred on (b)(6) 2021 while being used in a tfcc i-o method when two wire loops broke in a row.The case was completed using a new product, and there was no patient effect reported.Additional information provided (b)(6) 2021: the procedure being performed was a tfcc damage.The loop broke during passing.The tape came out of the bone hole and did not interfere with the operation.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1255-18 wire was received for investigation.Visual inspection identified that the wire had broken into two pieces.The pieces were noted to be severely bent.Assessment of the wire thickness with digital micrometer id: 224 identified that the device met design specifications.The observed condition is consistent with user-applied mechanical forces during use.

• Brand Name: SUTURE PASSING WIRE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13225889
• Report Number: 1220246-2022-04280
• Device Sequence Number: 14386171
• Product Code: LXH
• UDI-Device Identifier: 00888867006539
• UDI-Public: 00888867006539
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: SUTURE PASSING WIRE
• Device Catalogue Number: AR-1255-18
• Device Lot Number: 12650621
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown