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

Catalog Number	C6387
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken c6387 device 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 were 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 (b)(4) complaints, regarding 22 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).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.Precautions: avoid mechanical shock or over stressing the instrument which may shorten the life of the instrument.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the c6387, spectrum ii suture hook, disposable, large crescent, qty 5, device broke in the joint of the patient during a rotator cuff procedure on (b)(6) 2018.The component was retrieved causing a 20-minute delay in the procedure.It is reported that the patient was not injured during this event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II SUTURE HOOK, DISPOSABLE, LARGE CRESCENT, QTY 5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7531869
• Report Number: 1017294-2018-00069
• Device Sequence Number: 11150536
• Product Code: LXH
• UDI-Device Identifier: 10845854019887
• UDI-Public: (01)10845854019887(17)220904(30)1(10)863775
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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: Physician
• Device Expiration Date: 09/04/2022
• Device Catalogue Number: C6387
• Device Lot Number: 863775
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/22/2018
• Patient Sequence Number: 1