MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS {} BRD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71173377

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the points on the forceps were damaged.Back-up device available and used, but it was a competitor's device.No delay or injury reported.

Manufacturer Narrative

The associated complaint devices were returned for evaluation.The visual inspection of the returned forceps confirm the tips are damaged.These devices were manufactured in 2018.These devices show signs of significant wear and usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: RDCE FRCPS W/ PTS {} BRD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9339367
• MDR Text Key: 168861736
• Report Number: 1020279-2019-04069
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010519535
• UDI-Public: 03596010519535
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71173377
• Device Lot Number: 18ETCD025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1