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

Model Number 90128275

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  Injury  

Event Description

It was reported that during thr surgery, the threaded bolt of the locking mechanism of the bhr offset cup impactor broke inside the patient during impaction of the cup.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.

Manufacturer Narrative

It was reported that during thr surgery, the threaded bolt of the locking mechanism of the bhr offset cup impactor (90128275, 4076147) broke inside the patient during impaction of the cup.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 review of the complaint history for the cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the batch, other complaints were identified for the part and this will continue to be monitored.The production records were reviewed for the instrument reportedly involved in this incident.All the released instruments involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.This instrument had a lifespan of 2+ years and it is unknown how many surgical cycles it was involved in during this time.The instructions for use note in the preoperative section 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 instrument or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the instrument 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.

Manufacturer Narrative

A bhr offset cup impactor (90128275, 4076147) was returned for investigation.It was reported that during thr surgery, the threaded bolt of the locking mechanism of the broke inside the patient during impaction of the cup.A visual inspection was performed.There are marks and scratches across the whole length of the instrument, consistent with surgical use.The threaded bolt of the locking mechanism has broken away from the instrument.This confirms the reported complaint.A review of the complaint history for the cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the batch, other complaints were identified for the part and this will continue to be monitored.The production records were reviewed for the instrument reportedly involved in this incident.All the released instruments involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.This instrument had a lifespan of 2+ years and it is unknown how many surgical cycles it was involved in during this time.The instructions for use note in the preoperative section 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.¿ the root cause of the reported issue could not be determined conclusively.A potential root cause is general wear and tear which would not have existed on the instrument when originally produced and inspected by smith & nephew.If additional information becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.The returned instrument part cannot be repaired and will be retained.

• Brand Name: OFFSET CUP INTRODUCER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10733063
• MDR Text Key: 212974355
• Report Number: 3005975929-2020-00400
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010591531
• UDI-Public: 03596010591531
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128275
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 4076147
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention