MAUDE Adverse Event Report: ARTHREX, INC. OPENING JACK FASTENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OPENING JACK FASTENER
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-13430-03 opening jack fastener broke/threads stripped when trying to open the jack.This was discovered during use in a hto balance.The case was completed by using a new ar-13430-03.Additional information provided 09/16/2022: the ar-13430-03 broke inside of the patient and the broken fragment was retrieved with no patient harm.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-13430-03 serial/batch number: (b)(6) was received for investigation.Visual evaluation found that the thread relief is damaged.The screw pitch shows burrs and cracks, losing the thread edges.The root cause of the reported failure mode is undetermined.

• Brand Name: OPENING JACK FASTENER
• 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: 15484388
• Report Number: 1220246-2022-05545
• Device Sequence Number: 5256073
• Product Code: LXH
• UDI-Device Identifier: 00888867012929
• UDI-Public: 00888867012929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: OPENING JACK FASTENER
• Device Catalogue Number: AR-13430-03
• Device Lot Number: 221722
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown