MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE EMERGENCY SCREW; PLATE, BONE

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00057.Medical products: thinflap system cross-drive emergency screw, part# 91-6704, lot# unk.Thinflap system cross-drive emergency screw, part# 91-6904, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported the screws could not be gripped by the driver.No adverse events were reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered unconfirmed.The 1.5x4mm x-drive tf sd screw ea (part# 91-6704, lot# unk) was returned for investigation.The screws were visually evaluated and found to show signs of use.The screws both showed significant damage at the cross-drive interface on the head of the screw.Functional testing was done for retention using a driver 01-7390 lot 048760 and bit 15-1196 lot 406650.The blade was inserted into the driver and the screw, then the assembly was lifted by the screw to verify the cross-drive feature could support the weight of the blade and driver.The screw passed this retention test.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (91-6704) and the previous one year (from the notification date) regarding retention failure, (b)(4).The most likely underlying cause of the complaint cannot be determined.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 EMERGENCY SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9583759
• MDR Text Key: 191993153
• Report Number: 0001032347-2020-00056
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6704
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1