MAUDE Adverse Event Report: ARTHREX INC. DISPS KIT,TRANS-TIBIAL ACL W/O SAWBLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-1898S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2017
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.Lot number was not provided so device history record review cannot be performed.The device was requested/is expected for evaluation but has not yet been received.The casue of the event coule not be determined from the information available and without device evaluation.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.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported via medwatch (b)(4) that on (b)(6) 2017 (left knee arthroscopy procedure - acl reconstruction with autograft, possible menisectomy vs.Repair, lateral and medial), a nitinol wire from and ar-1898s transtibial acl disposable kit was positioned for a second acl screw.Tried to pull out the nitinol wire and was not able to remove.The surgeon used a pair of pliers on the wire and used a mallet to bang out the wire.The wire then broke inside the femur and inside part of the screw.A mini c-arm was used to verify that wire was in the joint.The surgeon confirmed wire was not in joint and wire was not retrieved.Approximately a 2cm piece remains in the patient bone.Patient was an (b)(6) year old female.Follow-up investigation: the remainder of the nitinol wire was disposed of and is not available to return for evaluation.

• Brand Name: DISPS KIT,TRANS-TIBIAL ACL W/O SAWBLADE
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7070101
• Report Number: 1220246-2017-00448
• Device Sequence Number: 16458881
• Product Code: GFA
• UDI-Device Identifier: 00888867022461
• UDI-Public: 00888867022461
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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 Catalogue Number: AR-1898S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/30/2017
• 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: 18 YR