MAUDE Adverse Event Report: EXACTECH, INC. SCREW

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2013.Baseplate loosening with 1 screw fracture.No action taken at this time.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h3: the complaint product is not available for analysis, as it remains implanted.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.Manufacturing data could not be reviewed because the manufacturing lot/serial information was not provided.There were no user-related issues reported that appear to have contributed to the reported event.The most likely underlying cause for the screw fracture could be attributed to a combination of applied axial torque and/or a bending moment created by attempting to drive the screw into dense bone.The most likely underlying cause for baseplate loosening reported could be attributed to insufficient bone growth into/onto the glenoid plate, which could result in aseptic loosening.However, these causes cannot be confirmed due to the lack of x-rays and information provided.Section h6: in a review of the labeling it is a known complication that a patient's age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.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 most likely cause of the screw fracture could be attributed to a combination of applied axial torque and/or a bending moment created by attempting to drive the screw into dense bone.The most likely underlying cause for baseplate loosening could be attributed to insufficient bone growth into/onto the glenoid plate, the fractured screw and the patients' underlying conditions to include age and weight.This device is used for treatment, not diagnosis without serial number unable to provide d4.Expiration date & h4.Without catalog number unable to provide g5.

Event Description

The cause of the event is not known.As of 14 march 2019, the patient has not had any intervention or revision for the loosened baseplate with a fractured screw.No additional information is provided.

• Brand Name: SCREW
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7548514
• MDR Text Key: 109370896
• Report Number: 1038671-2018-00478
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 88