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

Model Number	DISPS KIT,TRANS-TIB ACL W/O SAWBLD
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2018
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 risk manager will not release the device.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the sales rep that the facility contacted him regarding two events where the guide wire from the ar-1898s broke during use.He did not know the batch numbers, stating that the facility gave him two possibilities.He did not have dates of surgeries, believes one was this week (case (b)(4)) and one was last month (case (b)(4)).He states that in case (b)(4), the guide wire remained in the patient but when that was realized, they re-opened the patient to retrieve the wire.He states that in case (b)(4), it was removed prior to closing the patient.Additional information obtained (b)(6) 2018: risk manager has confirmed that this event (arthrex reference case (b)(4)) took place on (b)(6) 2018.Patient was in pacu when a post op x-ray was taken which showed the retained piece of the tibial guide pin.Patient had eaten post operatively at that point, requiring them to wait an additional 6 hours for surgical removal.Patient was admitted overnight.Patient then underwent successful removal of the guide pin to prevent any complications related to the retention of the guide pin.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/O 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: 7734484
• Report Number: 1220246-2018-00578
• Device Sequence Number: 19033969
• Product Code: GFA
• UDI-Device Identifier: 00888867022461
• UDI-Public: 00888867022461
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DISPS KIT,TRANS-TIB ACL W/O SAWBLD
• Device Catalogue Number: AR-1898S
• Device Lot Number: PENDING
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other