MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX DIRECTOR MRR ANGLED BULLET; ACCESSORIES,ARTHROSCOPIC

Model Number	71935072
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the tip of the acufex broke off after it was unpacked.It is unknown if there was a back-up device available or if there was a delay.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 71935072 acufex mrr director bullet intended for use in treatment was returned for evaluation.This is a reusable instrument.It was confirmed that a tooth was broken.Another tooth had a rolled tip.The tooth was not found.Striations marks were observed.The breakage is aligned with substantial force, entanglement during sterilization, or contact with another instrument or device.Per ifu 81101022 ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.These instruments are designed for repeated use with proper care and handling.¿ as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ACUFEX DIRECTOR MRR ANGLED BULLET
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10469984
• Report Number: 1219602-2020-01330
• Device Sequence Number: 2939614
• Product Code: NBH
• UDI-Device Identifier: 00885556533314
• UDI-Public: 00885556533314
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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 Model Number: 71935072
• Device Catalogue Number: 71935072
• Device Lot Number: 18LTN0002C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1