MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR VENTING CANNULA 2.3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 999904

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

Venting cannula broke off in femoral neck at the end of the case when the suction was put in at the appropriate time of the technique.Lower piece of cannula was left in patient, because it could not be retrieved without compromising the bone around the implant.

Manufacturer Narrative

The bhr venting cannula (999904, lot: 7245) reportedly involved in this incident was not returned for the inspection.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the instrument reportedly involved in this incident.Device history record review by supplier confirmed that all released instruments met specifications applicable at the time of production.A complaint history review was carried out on the supplied part and batch number which confirmed no other instances of complaints with the same batch number.In october 2018, a corrective & preventative action was initiated internally related to the 999904 instrument.Further actions will be undertaken as part of these corrective & preventative activities, including review and amendment of the product drawing and updated supplier controls.The interdisciplinary team determined that no further escalation with regards to inventory in the field will be performed for this instrument at this time.However, smith & nephew will continue to monitor for further trends within complaints as part of the corrective and preventative action activities.Without return of the actual instrument or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this particular case, our investigation remains inconclusive.

• Brand Name: BHR VENTING CANNULA 2.3MM
• Type of Device: PROSTHESIS, 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: 7227027
• MDR Text Key: 98647101
• Report Number: 3005975929-2018-00030
• Device Sequence Number: 1
• Product Code: NXT
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999904
• Device Lot Number: 7245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1