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

Model Number	PENTRTR SUTR RETRIEVR 15°UP CRVD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/29/2021, it was reported by a facility representative via sems that an ar-2167-2 suture retriever broke.This occurred during a shoulder rcr on (b)(6) 2021.The case was completed using a spare instrument, with no patient effect reported.
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
The complaint is confirmed upon review of the customer-provided photos, which display breakage at the distal end of the ar-2167-2 shaft.Additionally, discoloration was present across the assembly.As the device was not returned for physical evaluation, however, the cause of the event remains undetermined.

• Brand Name: PENTRTR SUTR RETRIEVR 15°UP CRVD
• 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: 13333609
• Report Number: 1220246-2022-04318
• Device Sequence Number: 5475361
• Product Code: LXH
• UDI-Device Identifier: 00888867026063
• UDI-Public: 00888867026063
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Model Number: PENTRTR SUTR RETRIEVR 15°UP CRVD
• Device Catalogue Number: AR-2167-2
• Device Lot Number: 26760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown