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

Catalog Number 97.14115

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

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 conmed representative reported an issue with the 3.4mmx 130mm suture hook, 45 degree left, item # 97.14115, unknown serial, that occurred on (b)(6) 2019 in (b)(6).It was reported only that "the hook during the surgery is broken" and noted that the procedure involved a (b)(6) male.Additional information obtained indicates that the procedure was for a shoulder instability.It was a first time the hook was used by the doctor and during the procedure while the hook was passing into the tissue the tip broke.The piece broken was found in the shoulder and removed with grasping forceps.It was confirmed there was no impact or injury to the patient and the procedure was successfully completed using a different instrument.No additional medical/surgical intervention was required for the patient and no fragment remained.No other information was made available.Although the fragment was removed, this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The customer's reported issue of the hook breaking off is confirmed.An evaluation and inspection of the returned used device confirmed the reported problem and found the suture hook broken off from the welded tip.There is evidence that the weld was performed 360 degree round the shaft however, the broken tip was not returned for evaluation.The device was most likely broken off due to excessive lateral force that was applied to the suture hook tip.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is also advised to always inspect suture needle for damage (i.E., worn, dull, bent or cracked) prior to use.Avoid lateral stresses to the instrument or device function may be compromised.If the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage and unintentional patient injury may result.This suture hook is a limited reuse device and should only be used up to 5 procedures.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3.4MMX 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: 9536337
• MDR Text Key: 198563528
• Report Number: 1017294-2019-00169
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 97.14115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR