MAUDE Adverse Event Report: ARTHREX, INC. GRAFTBOLT, TIBIAL; PROSTHESIS, RIB REPLACEMENT

Catalog Number AR-5100-08

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/11/2016

Event Type  Injury  

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 requested/is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that while performing an acl reconstruction procedure, the surgeon was attempting to use the 8mm tibial graftbolt.While trying to insert the graft bolt sheath, the tip of the implant broke apart.Most of the broken implant was retrieved, however the surgeon was unable to remove a small piece of the implant.He secured the remaining piece by placing an interference screw next to the implant and finished the procedure.Patient is an (b)(6) male.

• Brand Name: GRAFTBOLT, TIBIAL
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6140671
• MDR Text Key: 61298500
• Report Number: 1220246-2016-00544
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 00888867035751
• UDI-Public: 00888867035751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: AR-5100-08
• Device Lot Number: 10039258
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR