MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CAPSULOTOMY SCISSORS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	999907
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thr surgery the scissors didn't cut well anymore.The instrument is worn out and needs to replaced.There was no delay not injury reported.The surgery was finish with a regular scalpel.
Additional Manufacturer Narrative
It was reported that during a thr surgery the scissors didn't cut well anymore.The instrument is worn out and needs to replaced.There was no delay not injury reported.The surgery was finished with a regular scalpel.As of today, the instrument, which was used in treatment and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr capsulotomy scissors was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified and this will continue to be monitored.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, all the released instruments involved would have met manufacturing specifications at the time of production.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Bhr surgical technique states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".A risk management review was performed.No additional risks were identified as result of the reported event.There was no patient injury reported as a result of the instrument issue and no harm to the patient is anticipated.Therefore no further clinical assessment is warranted at this time.Without return of the actual instrument or further information we cannot further investigate or confirm the details supplied in this complaint and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: BHR CAPSULOTOMY SCISSORS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10176546
• Report Number: 3005975929-2020-00208
• Device Sequence Number: 16914465
• Product Code: NXT
• UDI-Device Identifier: 03596010504623
• UDI-Public: 03596010504623
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 999907
• Device Catalogue Number: 999907
• Device Lot Number: 1665
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 10/25/2020
• 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: Hospitalization; Required Intervention