MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 11; TRAY, SURGICAL, INSTRUMENT

Model Number 71430402

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/03/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure the gii ps hi flex isrt tr s1-2 11 broke while being use inside the patient.It is unknown if there was a delay.S&n back up was available to complete the procedure.Any other issue that could affect the patient's condition was not reported by this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during tka procedure the gii ps hi flex isrt tr s1-2 11 broke while being use inside the patient.Surgeon was using it while trialing for size between size 9mm and 11mm.It broke in half.All pieces recovered.Patient was not hurt nor did it change the outcome of the case in any way.S&n back up was available to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Sections a, b, d, e updated.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms a large piece of the side of the device broke off.The broken piece was returned with the device.This device show extreme signs of wear/usage.This device was manufactured in 2010.A medical investigation was conducted and this complaint from the united states reports that a trial insert broke while in use.It has been communicated that no information would be forthcoming.All the pieces were recovered.The patient was not hurt or impacted nor did it change the outcome of the case in any way.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints 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.A review of risk management files found that the reported failure was documented appropriately.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 11
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10452254
• MDR Text Key: 204332094
• Report Number: 1020279-2020-04207
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010493026
• UDI-Public: 03596010493026
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 71430402
• Device Catalogue Number: 71430402
• Device Lot Number: 10DM01037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/27/2020; 10/23/2020
• Supplement Dates FDA Received: 08/31/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 155