MAUDE Adverse Event Report: CONMED CORPORATION MOSQUITO GRASPER, STRAIGHT, 2.75MM X 65MM; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 17.6004

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer, (b)(6) orthopedics & rehab, reported an issue with the mosquito grasper, straight, 2.75mm x 65mm, item # 17.6004, serial # (b)(4) that was experienced on (b)(6) 2020.It was reported that the top of the graspers broke off during surgery.It is noted there was no impact or injury to the patient and the procedure was successfully completed with a 5-10 minute delay as a result of removing the broken piece.To date, although requested, no information has been made available.Please note to conmed's understanding, although approved for human use only, this device was used on a canine.Although there is limited information on this reported issue, due to the graspers breaking while being used in the "patient", this incident will be reported on the basis of malfunction with potential for injury upon reoccurrence as the fragment was removed.

Manufacturer Narrative

Conmed received one (b)(4) for evaluation.The customer's reported complaint of the top of the graspers broke off was confirmed based on device evaluation.The evaluation found the tip damaged and worn as well as the etching were also worn, however no root cause could be established.Please note the device had been used in the canine not human population.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user to inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Inspect instrument after use to ensure it has not been damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional information was provided.Confirmation was received that the device had been used on a canine during routine use in an appropriate size dog with an appropriate size small coronoid fragment.The graspers had been received on 8/18/20, and they were sterilized and put in rotation that day.The facility has several different pairs of graspers, and most of the surgeons only use these particular graspers on elbow arthroscopy procedures, which account for maybe one quarter of the case load.The device broke immediately upon insertion into joint and grasping small coronoid fragment.The piece of the instrument was arthroscopically removed.

• Brand Name: MOSQUITO GRASPER, STRAIGHT, 2.75MM X 65MM
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 11187065
• MDR Text Key: 241076688
• Report Number: 1017294-2021-00043
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

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
• Device Operator: Other
• Device Catalogue Number: 17.6004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1