MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC P/S HOUS COLLET S 3-8; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440001

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka, using ream through femoral trials.While reaming the ps box, the collet screw jammed in the femoral trial and could not be removed.This means the surgeon could not trial again as the collet was still attached to the femoral trial.It is unknown how surgery was completed.Surgery was less than or equal to 30mins delayed.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned gii ps reamthru fem trial left size 6 confirms the gii spc p/s hous collet s 3-8 is stuck to the device.Also the visual confirms the collet thumbscrew size 3-9, slotted washer and spring broke off the collet.These pieces were returned with the device.The device exhibits signs of extensive use and wear.A review of complaint history did not reveal additional complaints for the listed batch.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: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11941717
• MDR Text Key: 254370258
• Report Number: 1020279-2021-05005
• Device Sequence Number: 1
• Product Code: HRY
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 71440001
• Device Catalogue Number: 71440001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 08/24/2021; 10/21/2021
• Supplement Dates FDA Received: 08/24/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1