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	No Code Available (3191)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
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 device disposition is unknown.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via fda medwatch letter (mw5084931) that a piece of the nitinol guidewire (from the trans-tibial acl disposable kit) broke off.Additional information has been requested from the facility medwatch reporter but at this time no further information was received.

• 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
• MDR Report Key: 8574272
• Report Number: 1220246-2019-01073
• Device Sequence Number: 2182496
• 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
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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: 01/31/2023
• Device Model Number: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• Device Catalogue Number: AR-1897S
• Device Lot Number: F193914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other