MAUDE Adverse Event Report: ARTHREX, INC. REAMER ATTACHMENT-STYLE ZIMMER / HUDSON; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	REAMER ATTACHMENT-STYLE ZIMMER / HUDSON
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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.
Event or Problem Description
It was reported that during a procedure, the ar-600rzh, completely broke off during the case.The case was completed by using another ar-600rzh without further issue.No patient harm.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-600rzh, sn (b)(6) reamer attachment was received for investigation.Visual inspection identified that the zh attachment had broken into two pieces, with heavy corrosion present at the breakage sites.Metal fatigue was present, as both sections of the ar-6000rzh were chipped and cracked.A review of the device history record associated with the complaint serial number identified that the device was manufactured in 2015.This is in agreement with the condition of the fragmented device received, as previously detailed.As such, the most likely cause of the event is consistent with breakage due to wear and tear damage accumulated over repeated usage of the device.

• Brand Name: REAMER ATTACHMENT-STYLE ZIMMER / HUDSON
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11314060
• Report Number: 1220246-2021-02575
• Device Sequence Number: 11791433
• Product Code: HWE
• UDI-Device Identifier: 00888867111066
• UDI-Public: 00888867111066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: REAMER ATTACHMENT-STYLE ZIMMER / HUDSON
• Device Catalogue Number: AR-600RZH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other