MAUDE Adverse Event Report: ARTHREX, INC. PENTRTR SUTR RETRIEVR 15°UP CRVD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PENTRTR SUTR RETRIEVR 15°UP CRVD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2023
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 8/24/2023, it was reported by a distributor via sems-06015094 that an ar-2167-2 penetrator suture retriever was broken; the pliers had a broken tip.All fragments were retrieved from the patient and the case was delayed for five minutes.The case was completed using another device.This was discovered during a shoulder procedure on (b)(6) 2023, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-2167-2 batch 66235 was received for investigation.Functional testing was not conducted due to the damage to the instrument's jaw.Visual evaluation found that the jaw was broken.Signs of wear and tear as the laser marks are faded.The most likely cause(s) for the reported failure is prying/leveraging the device against bone.Or another instrument.

• Brand Name: PENTRTR SUTR RETRIEVR 15°UP CRVD
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17775130
• Report Number: 1220246-2023-07948
• Device Sequence Number: 6170232
• Product Code: LXH
• UDI-Device Identifier: 00888867026063
• UDI-Public: 00888867026063
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: PENTRTR SUTR RETRIEVR 15°UP CRVD
• Device Catalogue Number: AR-2167-2
• Device Lot Number: 66235
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown