MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM; PLATE, BONE

Model Number N/A

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported that the screw thread was deformed and could not be gripped by the driver.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection of the screw showed heavy marking on the screw head.Functional testing was then conducted with a 01-7390 driver handle lot 048760 and a driver blade 01-7690 lot 995080.The blade was inserted into the screw head and there was a lack of retention.The damage to the screw head is not allowing the blade to retain the screw.The dhr will not be reviewed as the lot number remains unknown.There is no indication of manufacturing defects and there are no updates to the risk documents needed.For this part (91-6704) and the previous one year (from the notification date) regarding retention failure, (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the fracture is the application of excessive force beyond what the product is designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10120197
• MDR Text Key: 194057148
• Report Number: 0001032347-2020-00261
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 91-6704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1