MAUDE Adverse Event Report: ARTHREX, INC. DISPS KIT,TRANS-TIB ACL W/O SAWBLD; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DISPS KIT,TRANS-TIB ACL W/O SAWBLD
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2019
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 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 (mw5089877) that the following incident occurred: nitinol guide wire broke off, undetected by md/staff during original acl repair.This (second) surgery was to remove broken piece which had since migrated.The facility has confirmed that the original acl repair surgery took place on (b)(6) 2019.The unretrieved fragment from the(b)(6) 2019 procedure was discovered when the patient had returned to the md's office presenting with knee pain and an x-ray was obtained.The facility did not know the actual arthrex part number of the guidewire.The facility confirmed that a second surgery took place on (b)(6) 2019 during which the previously unretrieved guide wire was located.The surgeon was not able to fully remove the unretrieved fragment from the patient.The facility had no additional information to provide.The sales rep who was present during the second surgery reported that the surgeon indicated that the guide pin might have gotten bent behind the screw and broken off.The rep also stated that the facility has since changed their procedures to now measure the pin and inspect it after removal to ensure the entire guide pin is taken out.Although the rep also did not have a confirmed arthrex part number of the device used, he did report that the facility/surgeon open an acl pin kit, ar-1898s, for every case.Therefore ar-1898s is the most likely part number and the guide pin is included in this kit.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/O SAWBLD
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9324377
• Report Number: 1220246-2019-01414
• Device Sequence Number: 2498723
• Product Code: MDM
• UDI-Device Identifier: 00888867022461
• UDI-Public: 00888867022461
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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 Model Number: DISPS KIT,TRANS-TIB ACL W/O SAWBLD
• Device Catalogue Number: AR-1898S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other