MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD OFFSET CUP INTRODUCER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	90128275
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during impact of the bhr cup, the instrument broke due to fatigue from multiple blows with a mallet.Backup device was available.
Additional Manufacturer Narrative
An offset cup introducer (90128275, 4076147) was received for investigation.It was reported that the instrument broke due to fatigue from multiple blows with a mallet.Visual inspection was performed which noted that the instrument shows signs of surgical use with marks and scratches along the length of it.The drive chain assembly is snapped at the tip of the threads.Functional evaluation was performed which deemed the function to be unacceptable as drive chain assembly is snapped into two pieces.This confirms the reported complaint.A complaint history review was performed which noted that no other similar complaints were identified for this batch.Similar complaints have been 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.This instrument had a lifespan of 2+ years and it is unknown how many surgical cycles it was involved in during this time.Based on the available information and the returned instrument the probable root cause is undetermined.If further information is received then the complaint will be reopened and investigated.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: OFFSET CUP INTRODUCER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9535238
• Report Number: 3005975929-2019-00466
• Device Sequence Number: 2768302
• Product Code: MDM
• UDI-Device Identifier: 03596010591531
• UDI-Public: 03596010591531
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90128275
• Device Catalogue Number: 90128275
• Device Lot Number: 4076147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 04/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1