MAUDE Adverse Event Report: EXACTECH, INC BONE SCREW, 6.5MM

Catalog Number 120-65-30

Device Problems Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was not returned for evaluation.

Event Description

Index surgery: (b)(6) 2009.Revision due to tendon damage and metal fragments in hip.

Event Description

It was reported that a patient was admitted for repair of tendons in left leg due to osteolysis.There were no devices removed.It was reported the patient, currently seems to be doing well.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00133, 1038671-2017-00134, 1038671-2017-00135, 1038671-2017-00136, 1038671-2017-00137 and 1038671-2017-00138.

Manufacturer Narrative

Added information, event update: upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event is osteolysis with tendon involvement.This procedure to repair the tendons was conducted approximately 10 months after the left knee revision of (b)(6) 2015.The tendon repair may have been the result of the (b)(6) 2015, revision, patient conditions, or a combination of the two.Corrected data: there were no devices removed; therefore, no devices to be returned or analyzed.

• Brand Name: BONE SCREW, 6.5MM
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6384100
• MDR Text Key: 69254231
• Report Number: 1038671-2017-00134
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K993082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

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
• Device Operator: Physician
• Device Expiration Date: 08/17/2013
• Device Catalogue Number: 120-65-30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention