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

Model Number	DISPS KIT,TRANS-TIB ACL W/ SAWBLD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/24/2022, it was reported by a sales representative via phone that an ar-1897s transtibial acl disposables kit had a nitinol wire that broke inside the patient.After surgeon inserter the nitinol wire in the femoral tunnel, a screw was placed in.However, while surgeon was screwing in the screw the back wall of the femur blew out and it caused just about 1mm of the nitinol wire to snap.Surgeon made an incision in the back of the knee in an attempt to get access to the nitinol wire but could not.Case was completed using a tightrope and additional screw from another manufacturer.There was a delay in the surgery of roughly one hour and a half.Sales representative could not confirm if additional anesthesia was administer due to delay in surgery.The lot number for ar-1897s transtibial acl disposables kit is unknown as well.This was discovered during a quad acl reconstruction procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14075205
• Report Number: 1220246-2022-04724
• Device Sequence Number: 16802543
• Product Code: GFA
• UDI-Device Identifier: 00888867022454
• UDI-Public: 00888867022454
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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 Model Number: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• Device Catalogue Number: AR-1897S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown