MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT, UCL SUTURE PASSING; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	DISPOSABLES KIT, UCL SUTURE PASSING
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2021
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 10/19/2021, it was reported by an arthrex employee via email that an ar-7715-4.5 ucl suture passing disposables kit label describes to have a #2 fiberloop with needle, #2 tigerloop with needle, and a curve needle with nitinol loop and ruler, which would make a total of 3 needles in the package; however, the total needle count is listed on label as 2.This was discovered during an unspecified time.Additional information: during the shoulder product quality complaints review meeting on 10/28/2021 this complaint was discussed and it was determined that a needle was left in a patient, which led to an additional surgery to remove the needle which was left behind.The label discrepancy was noticed as a result of the needle being left in the patient by the surgeon.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation and further investigation identified that the needle count on the label, shown as 2, is incorrect.There are 3 needles in the pouch and the label should read 3 qty.

• Brand Name: DISPOSABLES KIT, UCL SUTURE PASSING
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 12793559
• Report Number: 1220246-2021-03915
• Device Sequence Number: 19990916
• Product Code: GAT
• UDI-Device Identifier: 00888867042087
• UDI-Public: 00888867042087
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: DISPOSABLES KIT, UCL SUTURE PASSING
• Device Catalogue Number: AR-7715-4.5
• Device Lot Number: 14001949
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown