MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CURVED CUP INTRODUCER; PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/METAL,RESURFACING

Model Number 90128257

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/16/2020

Event Type  Injury  

Event Description

It was reported that during surgery while malleting the cup into neutral position, the loose end of the introducer got snapped off due to the force was applied.The loose metal fell on the patient and caused for a short delay.Nonetheless, the procedure continued on and had successful results.No injury nor delay was reported.A s&n backup device was available to finish the surgery.

Manufacturer Narrative

It was reported that during surgery while malleting the cup into neutral position, the loose end of the introducer got snapped off due to the force was applied.The loose metal fell on the patient and caused for a short delay.Nonetheless, the procedure continued on and had successful results.No injury nor delay was reported.A smith and nephew backup device was available to finish the surgery.As of today, the instrument, which was used in treatment, and additional information has been requested for this complaint but has not become available.A quality investigation has been performed to confirm the whereabouts of unreturned instruments such as bhr cup introducers and as of this time they are not within smith and nephew control.A review of the complaint history for the bhr curved cup introducer (part number 90128257, batch s0801109) was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.As the supplier is no longer in business and that there is no traceability within sap, the manufacturing records for this device cannot be reviewed.However, all the released instruments involved would have met manufacturing specifications at the time of production.The attached image has confirmed damage to the instrument, it can be seen that the square adapter has snapped off from the body of the instrument, this confirms the failure mode as reported.It is unknown how many cycles the instrument has been through over it's 11+ years lifespan.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.It should be noted that the surgical technique for bhr 04727 v2 45670103 revc 01/18 recommends to "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." without return of the actual instrument or further information we cannot further investigate or confirm the details supplied in this complaint.

• Brand Name: BHR CURVED CUP INTRODUCER
• Type of Device: PRSTHSS,HIP,SEMI-CONSTRAINED,METAL/METAL,RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10262282
• MDR Text Key: 198500580
• Report Number: 3005975929-2020-00245
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0801109
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention