MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE REAMER, 9MM LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1409LPF
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth) 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 requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device reported to be discarded.
Event or Problem Description
It was reported that the patient underwent a btb autograft acl repair procedure on (b)(6) 2017 and during the procedure, the 9mm low profile reamer broke as the surgeon was drilling the femoral tunnel.The reamer broke about 20mm deep and was removed.The case was completed without further incident.On (b)(6) 2017, the surgeon reached out to the rep to report that while observing the patient's post-op x-ray, it looked as if there was still metal from the reamer in the patient.The surgeon stated that he may have to schedule a revision surgery to re-scope the knee.Surgeon plans to observe patient over next several weeks to see if the piece drifts.If the piece moved then a revision surgery will be scheduled.If the pieces stays put the surgeon does not plan to go in to retrieve the fragment.Patient is a (b)(6) y/o male weighing (b)(6).

• Brand Name: FLEXIBLE REAMER, 9MM LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6321836
• Report Number: 1220246-2017-00016
• Device Sequence Number: 1007813
• Product Code: LXH
• UDI-Device Identifier: 00888867207516
• UDI-Public: 00888867207516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/10/2017

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: 10/01/2020
• Device Catalogue Number: AR-1409LPF
• Device Lot Number: 10015028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/10/2017
• 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: 20 YR
• Patient Weight: 90