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

Model Number	999904
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the device got cement stuck inside.A change of surgical technique had to be performed to finish the surgery.There was no delay nor injury reported.
Additional Manufacturer Narrative
A bhr venting cannula (999904, lot number unknown) was received for investigation.It was reported that the cannula had cement stuck inside, resulting in a change of surgical technique to finish the surgery.There was no delay nor injury reported.A visual inspection of the cannula was performed which noted marks and scratches across the length of the instrument consistent with surgical use.Laser marking is present for the part number only.The batch number laser marking has completely faded.Cement is stuck inside the instrument.The instrument is also slightly bent and damaged in two places.This confirms the reported complaint.Without a definitive lot number a complete complaint history review cannot be performed for the device involved.A review of the complaint history for the bhr venting cannula was performed using part numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.As no device lot numbers was provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The bhr surgical technique states: ¿examine instruments for wear or damage before use¿ and ¿use the recommended instruments and the recommended surgical technique¿.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.Based on the available information and returned instrument the probable root cause is an unintended use error.No corrective or preventative actions have been initiated as a result of the performed investigation.The instrument will be retained at aurora uk as it cannot be repaired.

• Brand Name: BHR VENTING CANNULA 2.3MM
• Common Device Name: 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: 10331797
• Report Number: 3005975929-2020-00269
• Device Sequence Number: 1073781
• Product Code: NXT
• UDI-Device Identifier: 03596010504609
• UDI-Public: 03596010504609
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• 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): 09/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 999904
• Device Catalogue Number: 999904
• Device Lot Number: N/A
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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: Required Intervention