MAUDE Adverse Event Report: CONMED CORPORATION ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number	C08-65
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint is confirmed.A visual examination found the cannula chipped off at the tip and the small detached piece from the tip of the cannula was returned for evaluation.However, the rest of the tip of the cannula is still intact.The locking nut rotates freely and the critical dimensions inspected per print could not find any discrepancies with the returned product.This is a technique-dependent device and the most likely cause of this suspected failure is user-related.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.(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 cannula prior to use to ensure they are in good physical condition.Advises that to avoid damaging seals and excessive leakage, do not use with devices larger than the specified cannula diameter.To avoid damage during use, do not use excessive force on cannula.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the distributor reported an issue with an adjustable retractor cannula, catalog # c08-65, lot: 201712261 that occurred (b)(6) 2019 during an arthroscopic rotator cuff repair.It was reported that "during the surgery, the part of tip of this product was shaved off.Fortunately, the shaved piece was found and removed from the patient's body." it is indicated that there was no impact or injury to the patient and the procedure was successfully completed with no reported delay.Additional information obtained indicates that there was no problem with insertion of the cannula.The only available information about what device(s) were used with the cannula was that a shaver was used.It is indicated that the shaved piece that fell off of the cannula was retrieved from the patient with the vacuuming of waste liquid.Although asked, no other information was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (fragmentation falling in the patient).

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8506454
• Report Number: 1320894-2019-00092
• Device Sequence Number: 1466063
• Product Code: NBH
• UDI-Device Identifier: 00653405001631
• UDI-Public: (01)00653405001631(17)221225(10)201712261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 12/25/2022
• Device Catalogue Number: C08-65
• Device Lot Number: 201712261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1