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

Catalog Number	AR-1897S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2017
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 one end of the guide pin was broken-off.The pin broke-off approximately at the second laser line, and the broken end was slightly bent.The device met all material specifications as received.Complainant's event is typically caused by user mechanical damage to the device such as prying/leveraging or excessive bending forces of mating instruments over the guidewire.This is the first complaint of this type for this part/lot combination.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 via medwatch ((b)(4)): during a left knee trans-arthrosporic anterior cruciate ligament allograft, prior patellar tendon btb graft from the patient autograft as well as a partial medial meniscectomy, 2cm of the guide wire tip broke off in the 7mm cannulated silk screw.Surgeon made decision to leave broken tip in patient.Follow-up investigation: x-rays were taken post-op to confirm the location of the broken tip.

• Brand Name: DISPOSABLE KIT,TRANS-TIBIAL ACL W/ 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: 6983482
• Report Number: 1220246-2017-00390
• Device Sequence Number: 444240
• Product Code: GFA
• UDI-Device Identifier: 00888867022454
• UDI-Public: 00888867022454
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 10/01/2021
• Device Catalogue Number: AR-1897S
• Device Lot Number: 10072041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/27/2017
• 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