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

Model Number 71674080

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 01/03/2021

Event Type  malfunction  

Event Description

It was reported that, during intertan nailing, the gripper was not holding the wire so the surgeon could not hold the wire.Procedure finished with s&n backup device.No surgical delay or injury to patient reported due this event.

Manufacturer Narrative

Results of investigation: the device, used in treatment was returned for evaluation: a visual inspection was performed and confirmed the spring that¿s connected to the handle appears to not be catching with any friction when squeezing the handle, which may cause it to not function as intended and reduce accuracy.The device shows signs of extensive wear/usage.The manufactured date for this device is 2016.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GRIPPER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11221239
• MDR Text Key: 234789703
• Report Number: 1020279-2021-00550
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010560766
• UDI-Public: 03596010560766
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: 71674080
• Device Catalogue Number: 71674080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/24/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1