MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CAPSULOTOMY SCISSORS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	999907
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection the device was found broken.No case involved.
Additional Manufacturer Narrative
Capsulotomy scissors (999907, 16453), was received for investigation.It was reported that upon inspection the device was found broken.No case involved.The production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Visual inspection noted that there were scratches across the device.A functional evaluation was performed, which showed that one of the blades of the scissors had snapped off, resulting to no function.This confirms the reported failure mode.Based on the available information, the proposed probable root cause is fracture problem, resulting in the blade from the scissors being broken off.

• Brand Name: BHR CAPSULOTOMY SCISSORS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10383260
• Report Number: 3005975929-2020-00286
• Device Sequence Number: 19429501
• Product Code: LXH
• UDI-Device Identifier: 03596010504623
• UDI-Public: 03596010504623
• Combination Product (Y/N): N
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 999907
• Device Catalogue Number: 999907
• Device Lot Number: 16453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/09/2020
• 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