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

Model Number	71674080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after surgery, the gripper was not gripping the guide rod as tight as it should, defective spring.No injury reported.No delay.After product evaluation it was determined that the gripper has a broken release lever.

• Brand Name: GRIPPER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11776791
• Report Number: 1020279-2021-03738
• Device Sequence Number: 3550722
• Product Code: LXH
• UDI-Device Identifier: 03596010560766
• UDI-Public: 03596010560766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71674080
• Device Catalogue Number: 71674080
• Device Lot Number: 18GSP0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1