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

Model Number	90128275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that the item was found broken while outside the patient.No delay reported.No patient injuries reported.An s&n backup was available.
Additional Manufacturer Narrative
H3, h6: an offset cup introducer (90128275, 3446822) was returned for investigation.It was reported that the item was found broken while outside the patient.A review of the complaint history for the offset cup introducer was performed using part and 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.The production records were reviewed for the devices reportedly involved in this incident.The released devices involved met manufacturing specifications at the time of production.Non-conformance was identified for the rejected devices.There are visible marks and scratches across the device, consistent with surgical use.Drive chain mechanism is broken.A functional evaluation is not required as the part was confirmed to be broken.This confirms the reported complaint.It is unknown how many cycles the instrument has been through over it's 3+ years lifespan.Based on the available information, the proposed probable root cause for the failure is improper routine maintenance.Smith and nephew recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No preventative or corrective action has been initiated as a result of this investigation.The device cannot be repaired and will be retained.

• Brand Name: OFFSET CUP INTRODUCER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11282126
• Report Number: 3005975929-2021-00072
• Device Sequence Number: 4371953
• Product Code: NXT
• UDI-Device Identifier: 03596010591531
• UDI-Public: 03596010591531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 3446822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1