MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IMPACTOR PAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/27/2023, it was reported by a sales representative via sems that an 0837-000 impactor pad broke.This occurred during a tibial nail procedure on 03/25/2023 during one of the malleting strikes the pad broke.The threaded portion of the pad broke right off at the base and the shaft/impactor pad itself fell off.When back-slapping to create compression a few minutes later, the threaded portion came out of the "jig".
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged 0837-000 serial/batch number (b)(4) was received for investigation.Functional testing was not performed due to that the device was damaged.Visual evaluation found that the impactor threaded part was broken.The cause remains undetermined.

• Brand Name: IMPACTOR PAD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16815477
• Report Number: 1220246-2023-06594
• Device Sequence Number: 5734015
• Product Code: LXH
• UDI-Device Identifier: 00848665013559
• UDI-Public: 00848665013559
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: IMPACTOR PAD
• Device Catalogue Number: 0837-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown