MAUDE Adverse Event Report: ARTHREX INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1409LP-50
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the device's flutes were broken-off.The device met all material specifications as received.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive drilling forces being applied during use.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported by the representative that during an acl procedure, the guide wire was introduced, went straight in, then the reamer was put over top of the wire.When it came in contact with the bone the entire head of the reamer broke off.It never made it into the joint.It broke when it made contact with the cortex.Opened a different manufacturer's reamer and completed the procedure without incident.Patient: (b)(6) female.The broken piece was never found but it was confirmed by the surgeon that it did not remain in the patient.Surgeon did not order x-rays.Follow-up investigation: the reamer head broke into two pieces.One piece was recovered and has been returned for evaluation with the shaft.The sales rep states that surgeon felt and also visualized the incision a second time before closing.The device piece was not located.

• Brand Name: REAMER, LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7502472
• Report Number: 1220246-2018-00180
• Device Sequence Number: 19219890
• Product Code: LXH
• UDI-Device Identifier: 00888867016774
• UDI-Public: 00888867016774
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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 Expiration Date: 05/01/2022
• Device Catalogue Number: AR-1409LP-50
• Device Lot Number: 10143813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR