MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL PIN DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71513331

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 06/17/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure the pin capture was found to be loose.It is not holding pins anymore.No delay.Procedure could be finished using the same defective device but the surgeon had to change in surgical technique to complete the surgery.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirms the entry point of the pin drivers were the connection of the pin goes is severely damaged.This device shows significant signs of wear/usage.This device was manufactured in 2013.A functional evaluation confirmed the stated failure.The driver would not hold a.123 pin gage as intended.A medical investigation will be performed.Proceed based on information provided / available for the investigation; if no relevant clinical information is provided, recommend closure.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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.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.

• Brand Name: UNIVERSAL PIN DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262191
• MDR Text Key: 198486313
• Report Number: 1020279-2020-03119
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010589064
• UDI-Public: 03596010589064
• 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
• Report Date: 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2013
• Device Model Number: 71513331
• Device Catalogue Number: 71513331
• Device Lot Number: 13AM13069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention