MAUDE Adverse Event Report: ARTHREX, INC. HOLDING SLEEVE, 2.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HOLDING SLEEVE, 2.0MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the inner collet broke in two.The id of the broken fragment met specifications.The prongs of the broken fragment are also bent, dented and discolored.The cause of the event is undetermined.
Event or Problem Description
On 12/07/2021, it was reported by a facility representative via sems that a ar-18700-49 clamp, and a r-18700-25 sleeve are broken.This occurred on (b)(6) 2021 during a procedure.There was no patient effect reported.

• Brand Name: HOLDING SLEEVE, 2.0MM
• 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: 13087984
• Report Number: 1220246-2021-04214
• Device Sequence Number: 14723786
• Product Code: LXH
• UDI-Device Identifier: 00888867312746
• UDI-Public: 00888867312746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 12/27/2021

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: HOLDING SLEEVE, 2.0MM
• Device Catalogue Number: AR-18700-25
• Device Lot Number: 1391947
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown