MAUDE Adverse Event Report: EXACTECH, INC EXACTECH SCREWS

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Patient presents with intense pain in both legs, more on the right than the left.Sharp, shooting sensations everytime he walks or puts pressure on his foot.The case report form indicates the event is definitely not related to devices and definitely not related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Upon review of this event, it is found not to meet the definition of a complaint, as there is no alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.There is no reasonable causality between the device in the left hip to the pain the patient experienced in the right leg.Purposed date of surgery as noted from database (b)(6) 2016.

Event Description

It was reported that a patient stated that he was having intense pain in both legs, more so on the right than the left.He was having sharp shooting sensation every time he walks or put pressure on the foot.Patient states this started early in the morning.He states his right leg is swollen and slightly red, notice veins bulging.Patient was advised to ice and elevate for 2-3 hours and avoid doing any activities, nurse will call the hospital to have a nurse rule out dvt.Patient presented to the er, then admitted for observation.Admitted for less than 24 hours.Associated mfrs: 1038671-2017-00004, 1038671-2017-00005, 1038671-2017-00006, 1038671-2017-00007, and 1038671-2017-00008.

• Brand Name: EXACTECH SCREWS
• Type of Device: SCREWS
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 6237570
• MDR Text Key: 64362135
• Report Number: 1038671-2017-00008
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 108