MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC P/S HOUS COLLET S 3-8; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR

Model Number 71440001

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

It was reported that upon inspection noticed that the small knob was broken off.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned genesis ii spc fixed housing collet confirms the knob broke off.The broken piece was returned.The device was manufactured in 2009.The device exhibits signs of extensive use and wear.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a 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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII SPC P/S HOUS COLLET S 3-8
• 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: 10188617
• MDR Text Key: 196224799
• Report Number: 1020279-2020-02696
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556033401
• UDI-Public: 00885556033401
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440001
• Device Catalogue Number: 71440001
• Device Lot Number: 09HM02704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1