MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR

Model Number 71440145

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

It was reported that during office kit - efip inspection the reamer was dull.No case involved.No injury reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the housing reamer dome is dull.The lot number can¿t be read on this device.This device shows signs of extreme wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• Brand Name: GII P/S CONS HOUSING REAM DOME
• Type of Device: PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10205215
• MDR Text Key: 196743557
• Report Number: 1020279-2020-02814
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010471338
• UDI-Public: 03596010471338
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 71440145
• Device Catalogue Number: 71440145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1