MAUDE Adverse Event Report: EXACTECH, INC. REVERSE TORQUE DEFINING SCREW ASSEMBLY

Catalog Number 320-11-00

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Joint Disorder (2373)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2015.Revision of right shoulder components due to dislocation.It is unknown whether the patient fell before or after dislocating.This event report was received thorugh clinical data collection activities.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level, or trauma would cause the surgeon to expect early failure of the system.Postoperative revisions or surgical interventions are a known complication found in joint replacements.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 revision on the right shoulder joint devices is most likely related to over activity, a fall, and patient underlying conditions to include age and previous shoulder maladies.This device is used for treatment, not diagnosis.

Event Description

The patient was "mopping" and it is unclear if the shoulder was dislocated with that or with a fall that the patient suffered.No additional information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00235, 1038671-2017-00237, 1038671-2017-00238 and 1038671-2017-00239.

• Brand Name: REVERSE TORQUE DEFINING SCREW ASSEMBLY
• Type of Device: SCREW ASSEMBLY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6515895
• MDR Text Key: 73494933
• Report Number: 1038671-2017-00236
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

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 Catalogue Number: 320-11-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 82