MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE RATCHET DRIVER; ACCESSORIES,ARTHROSCOPIC

Model Number	72201888
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during lcp, lca and lcm arthroscopy procedure, the biosure ratchet driver broke in the doctor's hands.The instrument was inside the patient.No delay and the same device was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one 72201888 biosure ratchet driver, has not retuned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.The information provided states: ¿during lcp, lca and lcm arthroscopy procedure, the biosure ratchet driver broke in the doctor's hands¿.This is a four-year-old device.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include improper cleaning of device.The instruction for use states: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc¿.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: BIOSURE RATCHET DRIVER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10428786
• Report Number: 1219602-2020-01286
• Device Sequence Number: 3273701
• Product Code: NBH
• UDI-Device Identifier: 03596010615442
• UDI-Public: 03596010615442
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72201888
• Device Catalogue Number: 72201888
• Device Lot Number: 50614615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention