MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 4MM; BONE SCREW

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country - (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the screw signs of significant wear.There was some minor damage to the threads and the cross-drive interface was extremely damaged.There incorrect blade usage may is a potential contributor but could not be confirmed.There is no indication of manufacturing defects.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied to the screw.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported "nut wear".Additional information was requested and the distributor responded "the screw head did attrited during surgery." there was approximately a five minute delay, the surgeon replaced the screw with a new screw.No adverse events have been reported as a result of the malfunction.Upon evaluation of the screw it was determine the screw head was damaged.

• Brand Name: "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 4MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8007313
• MDR Text Key: 125794064
• Report Number: 0001032347-2018-00705
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 95-6104
• Device Lot Number: 942190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1