MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC ACF EXT ROT PAD LT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71441253

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/29/2020

Event Type  Injury  

Event Description

It was reported that during procedure the surgeon pulled pin to remove and the instrument came apart and needs replaced.It was inside the patient.The procedure was completed without delay with the same device.

Manufacturer Narrative

Results of investigation: the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is shattered, damaged and has signs of wear and tear from use.The device was manufactured in 2012.According to clinical/medical investigation , per complaint details, the device malfunctioned during use.Based on the information provided the patient injury, impact could not be concluded.Additionally it is unknown if there was any delay in the procedure or if any part remained in the patient.No health consequences or impact has been reported.Smith and nephew has not received adequate materials 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 review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the lot.¿at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Internal complaint reference: (b)(4).

• Brand Name: GII SPC ACF EXT ROT PAD LT
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10607341
• MDR Text Key: 209194648
• Report Number: 1020279-2020-04972
• Device Sequence Number: 1
• Product Code: MBH
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71441253
• Device Lot Number: 12EM08980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention