MAUDE Adverse Event Report: CONMED CORPORATION 3.4MM X 130MM SUTURE HOOK, 45 DEGREE LEFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 97.14115

Device Problems Material Disintegration (1177); Device Damaged by Another Device (2915); Scratched Material (3020)

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

Event Date 12/14/2020

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

On behalf of the customer, the distributor in (b)(4) reported issues with the 3.4mm x 130mm suture hook, 45 degree left, item # 97.14115, sn# (b)(4).It was reported that on (b)(6) 2020 during a rotator cuff repair involving a (b)(6) year old male, the surgeon inserted 97.14115 into a c7367 cannula.The inner side of cannula was strongly scratched by the suture hook and caused debris inside of the patient.The debris was removed using suction.The surgeon successfully completed the surgery with an alternate 97.10015 causing approximately 6minute delay.It is indicated that there was no impact or injury to the patient.Although there is no actually allegation of defect against the suture hook, it is stated the device caused scratching and debris (fragmentation) to fall into the patient, however it was removed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Conmed received one suture hook, item 97.14115 however the cannula, item c7367 was not returned for the evaluation.The evaluation and inspection of the retuned used device, item 97.14115 could not confirm any issues with returned device.The device inspection was performed per design print and tool t50-003-220, the cannula function gauge.No fault was found.It is suspected that the customer may be using incorrect cannula.Per design print 97.14115, note 3, tip configuration must fit into an 8.2mm cannula.The reported event and customer's complaint are unconfirmed.The manufacturing documents from the device history record and lot history record have been reviewed and found no abnormalities that would contribute to this issue.The service history was reviewed and no data was found.A two-year review of complaint history revealed there has been a total of 1 complaints, regarding 1 devices, 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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that prior to use, always inspect and test the instrument for proper function by passing usp #1 monofilament through handle and hook.Do not use if parts are broken, cracked or worn, or device function may be compromised.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3.4MM X 130MM SUTURE HOOK, 45 DEGREE LEFT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 11155113
• MDR Text Key: 268254014
• Report Number: 1017294-2021-00017
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• 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: Health Professional
• Device Catalogue Number: 97.14115
• Device Lot Number: 1071564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C7367 CANNULA
• Patient Age: 61 YR