MAUDE Adverse Event Report: EXACTECH, INC. LOCKING SCREW, SIZE 0

Catalog Number 308-15-01

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

The patient dislocated and underwent manipulation under anesthesia.

Event Description

It was reported from the united kingdom that a male patient experienced several shoulder dislocations after an hrp (hemiarthroplasty).Patient had manipulation under anesthesia (mua) on (b)(6) 2017.The patient dislocated again on (b)(6) 2017 but does not want any treatment.The patient took off the abduction wedge and went home from the hospital the same day of the mua against the surgeon's advice.He remained under follow-up and appeared compliant.The patient had agreed to a revision, which was planned for (b)(6) 2018.There is no indication that there was a device problem or malfunction.No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00793, 1038671-2017-00794, 1038671-2017-00795.

Manufacturer Narrative

A search was made of 2017, 2018 and 2019 complaint documentation and there is no other complaint/s with the reported catalog and serial numbers of this event.There is no information to indicate this patient had a surgical revision.In a review of the labeling it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and that fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, may require a second surgical intervention or revision.It is known that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of shoulder dislocations is most likely related to the patients' underlying conditions and medical noncompliance.This device is used for treatment not diagnosis.

• Brand Name: LOCKING SCREW, SIZE 0
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6988227
• MDR Text Key: 90591288
• Report Number: 1038671-2017-00796
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K143659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 308-15-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention