MAUDE Adverse Event Report: ARTHREX, INC. HANDLE, QC, RATCHETING, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HANDLE, QC, RATCHETING, CANNULATED
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during a pilon fracture procedure the rep had to go through multiple trays to find a working ar-8950rh ratcheting handle.A quantity three ar-8950rh would not ratchet either way.During the same procedure the tip of the ar-13120g-2, mini depth guide snapped off and a second one had to be opened.The sales rep reported the case was completed and there was no harm or injury to the patient.Additional information has been requested.Additional information received on 03/18/2020: the rep reported all broken pieces were fully accounted for as no pieces broke while in the patient.The depth guide needle broke and went flying into the corner of the operating room, and the ratcheting handles were discovered broken before they were used on the patient.The sales rep reported the case took longer than expected so the patient was undoubtedly exposed to a longer dose of anesthesia.The case was completed by using the depth gauge from the 3.0mm instrument caddy as it fits in the holes drilled with a 1.7mm drill bit.

• Brand Name: HANDLE, QC, RATCHETING, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9935386
• Report Number: 1220246-2020-01781
• Device Sequence Number: 754617
• Product Code: LXH
• UDI-Device Identifier: 00888867133259
• UDI-Public: 00888867133259
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HANDLE, QC, RATCHETING, CANNULATED
• Device Catalogue Number: AR-8950RH
• Device Lot Number: 78421748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other