MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 DEPTH GAUGE; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 71364451

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

Tip of depth gauge broke while attempting to measure screw length.No backup was available.No delay to procedure recorded.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned r3 depth gauge indicated the tip fractured off, confirming the stated complaint.This device was manufactured in 2013, showing signs of wear from use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.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.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 DEPTH GAUGE
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8370515
• MDR Text Key: 137157213
• Report Number: 1020279-2019-00810
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010599438
• UDI-Public: 03596010599438
• Combination Product (y/n): N
• PMA/PMN Number: K093047
• 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: 03/20/2019

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: 71364451
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1