MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, TRANS-TIBIAL ACL W/O SAWBLADE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-1898S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
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.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.This type of event is most likely caused by the use of excessive force over the guide pin, the driver tip hitting a flex point of the guide pin, prying and/or leveraging on the guide pin or re-using a guide pin from the single-use disposables kit that had been bent from prior 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 reported via a medwatch (b)(4) that the guidewire/pin broke during the attempted removal from the interference screw at the 30 mm mark.Patient (b)(6).Additional information obtained 2/6/17: the procedure was an acl reconstruction.An un-retrieved fragment approximately 30 mm remained within the screw in the femoral tunnel inside the patient.The fragment was confirmed via fluoroscopy.The procedure was completed.

• Brand Name: DISPOSABLE KIT, TRANS-TIBIAL ACL W/O SAWBLADE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6367774
• Report Number: 1220246-2017-00046
• Device Sequence Number: 16288280
• Product Code: MDM
• UDI-Device Identifier: 00888867022461
• UDI-Public: 00888867022461
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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-1898S
• Device Lot Number: 10033512
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/01/2017
• 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: 65 YR