MAUDE Adverse Event Report: CONMED LARGO 4.75/5.5 MM ARGO KNOTLESS REUSABLE SMOOTH PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	K4755RSP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer against the reported device, k4755rsp, 4.75/5.5 mm argo knotless reusable smooth punch, was being used during a rotator cuff repair procedure on (b)(6) 2023 when it was reported, ¿i had a surgeon who used the k4755rsp for a rotator cuff repair.When he began to mallet the punch into the bone a sliver of metal came off inside the joint.When we removed the punch, it looked completely fine so i can't really be sure as to why this happened other than maybe some leftover material was on the tip of the punch from manufacturing?¿.A series of assessment questions were sent and it was reported the device did fragment but it was retrieved with the shaver suction.There was a reported delay of a few minutes and another punch was used to complete the surgery.There was no report of patient or user impact, medical intervention, or extended hospitalization for the patient this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet returned.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: that proper alignment of instruments is important during implantation of the argo knotless anchor to minimize possible breakage of an anchor.Breakage of the argo knotless anchor is possible if: the drill bit and punch are not inserted to the proper depth; the argo knotless anchors are not properly aligned with the pilot hole; the argo knotless anchors are loose or not securely attached on the driver; the argo knotless anchors inserter is used for prying; the argo knotless anchors are advanced too deep.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer against the reported device, k4755rsp, 4.75/5.5 mm argo knotless reusable smooth punch, was being used during a rotator cuff repair procedure on (b)(6) 2023 when it was reported, ¿i had a surgeon who used the k4755rsp for a rotator cuff repair.When he began to mallet the punch into the bone a sliver of metal came off inside the joint.When we removed the punch, it looked completely fine so i can't really be sure as to why this happened other than maybe some leftover material was on the tip of the punch from manufacturing?¿.A series of assessment questions were sent and it was reported the device did fragment but it was retrieved with the shaver suction.There was a reported delay of a few minutes and another punch was used to complete the surgery.There was no report of patient or user impact, medical intervention, or extended hospitalization for the patient this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.75/5.5 MM ARGO KNOTLESS REUSABLE SMOOTH PUNCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16642062
• Report Number: 1017294-2023-00027
• Device Sequence Number: 20345741
• Product Code: LXH
• UDI-Device Identifier: 30653405988353
• UDI-Public: (01)30653405988353(11)230112(10)1293461
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: K4755RSP
• Device Catalogue Number: K4755RSP
• Device Lot Number: 1293461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic