MAUDE Adverse Event Report: ARTHREX, INC. CANNULATED CORING REAMER 8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CANNULATED CORING REAMER 8MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/12/2019
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 requested/is expected but has 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 cannulated coring reamer, ar-8901cr, trephine was loaded onto a drill.The surgeon then began to ream.When he contacted the bone the reamer ¿blew out.Reforming the reamer to resemble a mushroom.Mushroom meaning ¿blowing out¿.No further information provided.Further information requested.Additional information provided on 4/16/2019: the procedure performed was a calcaneus osteomyelitis.The case was completed by aborting the specific procedure, harvesting bone dowel from calcaneus.
Additional Manufacturer Narrative
Complaint confirmed, the distal end of the device was found to have symmetrical damage with each teeth bent outward.The damage was found to most likely be caused by using a power drill instead of the manual handle shown in the surgical technique.

• Brand Name: CANNULATED CORING REAMER 8MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8600127
• Report Number: 1220246-2019-01087
• Device Sequence Number: 1981597
• Product Code: LXH
• UDI-Device Identifier: 00888867048720
• UDI-Public: 00888867048720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: CANNULATED CORING REAMER 8MM
• Device Catalogue Number: AR-8901CR
• Device Lot Number: 031546
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other