MAUDE Adverse Event Report: CONMED CORPORATION SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, QTY 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	C6381
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken c6381 is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 24 complaints, regarding 25 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 0.0004.Per the instructions for use, the user is advised the following: warnings: 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.Avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Do not use if parts are broken, cracked or worn, or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported on behalf of their customer that the c6381 device was being used during a bankart procedure on (b)(6) 2020 when the device tip broke in the patient.It was reported that all pieces were removed from the patient.The procedure was completed with an alternate device after a 2-minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, QTY 5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 9642224
• Report Number: 1017294-2020-00020
• Device Sequence Number: 2449501
• Product Code: LXH
• UDI-Device Identifier: 10845854019863
• UDI-Public: (01)10845854019863(17)240604(30)1(10)1030438
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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 Expiration Date: 06/04/2024
• Device Model Number: C6381
• Device Catalogue Number: C6381
• Device Lot Number: 1030438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1