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

Catalog Number	71674080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: case (b)(4).
Event or Problem Description
It was reported that during a im nail procedure, one (1) gripper was found broken, no longer functioning as expected.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: additional information received by the manufacturer.It has been identified that this event should be re-evaluated for mdr reporting.The new information states that the device is no longer functioning as expected showing signs of significant wear and use such as , scratches, burrs, and gouges in the metal.There are no pieces broken off or on the device.The device issue may require use of a replacement or alternate device to complete the surgical procedure and may result in a short delay while that alternate device is obtained.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GRIPPER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18423042
• Report Number: 1020279-2023-02644
• Device Sequence Number: 15445113
• Product Code: LXH
• UDI-Device Identifier: 03596010560766
• UDI-Public: 03596010560766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: 71674080
• Device Lot Number: 07KCT0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 12/31/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown