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

Catalog Number	AR-1409LPF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 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.
Event or Problem Description
It was originally reported that the reamer broke in half while drilling the femoral tunnel.Nothing was left in the patient; this was confirmed with x-rays and the acl case was completed.Patient male, (b)(6).Additional information obtained 6/13/2017 via medwatch (b)(4): date of procedure was (b)(6) 2017.An arthroscopic repair of the knee was being performed.The disposable instrument being used was an arthrex low profile flexible reamer 9 mm, ar-1409lp, lot 10034654.The instrument was inserted into the knee and used for reaming.The instrument was then removed from the knee and placed on the sterile table.It was then noted that a small piece of the flexible metallic portion had broken off and was missing.This piece had not been missing before the instrument was used.The missing area was approximately 5 mm x 5 mm.Doctor was notified and the surgical area was inspected but the missing piece could not be located.The surgery proceeded without complications and an x-ray of the knee was obtained before the surgical site was closed.The x-ray was found to be negative by the doctor and the x-ray was also sent by the x-ray tech to be read by a radiologist.The surgical site was closed and bandaged as usual.
Additional Manufacturer Narrative
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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation of the returned device revealed that the flex link was broken off approximately at the start of the flex pattern between the laser markings.The device met all material specification 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 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.
Event or Problem Description
It was originally reported that the reamer broke in half while drilling the femoral tunnel.Nothing was left in the patient; this was confirmed with x-rays and the acl case was completed.Patient male, (b)(6) years old.Additional information obtained 6/13/17 via medwatch (b)(4): date of procedure was (b)(6) 2017.An arthroscopic repair of the knee was being performed.The disposable instrument being used was an arthrex low profile flexible reamer 9mm, ar-1409lp, lot 10034654.The instrument was inserted into the knee and used for reaming.The instrument was then removed from the knee and placed on the sterile table.It was then noted that a small piece of the flexible metallic portion had broken off and was missing.This piece had not been missing before the instrument was used.The missing area was approximately 5 mm x 5 mm.Doctor was notified and the surgical area was inspected but the missing piece could not be located.The surgery proceeded without complications and an x-ray of the knee was obtained before the surgical site was closed.The x-ray was found to be negative by the doctor and the x-ray was also sent by the x-ray tech to be read by a radiologist.The surgical site was closed and bandaged as usual.

• Brand Name: FLEXIBLE REAMER, 9 MM LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6642771
• Report Number: 1220246-2017-00215
• Device Sequence Number: 11089331
• Product Code: LXH
• UDI-Device Identifier: 00888867207516
• UDI-Public: 00888867207516
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: 02/01/2021
• Device Catalogue Number: AR-1409LPF
• Device Lot Number: 10034654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 08/16/2017
• 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: 31 YR