MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM 1.65 X 5MM HIGH TORQUE SELF DRILLING CROSS DRIVE SCREW; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional 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.Medical products: 1.5mm system high torque (ht),sd,x-dr,screw 1.5mm x 5mm, part# 91-6105., lot# unk.1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# unk.Htr-pekk compto rt ft sp pa te, part# pk623109, lot# 976410.1.5mm system 2x3 hole rectangle plate, part# 01-7136, lot# unk.1.5mm system 6 hole regular double y plate, part# 01-7110, lot# unk.
Event or Problem Description
It was reported that two (2) screws fractured during implantation of a custom cranial plate.The procedure was completed with alternative screws.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.Product was not returned for investigation and no photos were provided.For these reasons, no visual inspections or functional testing could be conducted.The dhr could not be reviewed due to the lot numbers remaining unknown.There are no indications of manufacturing defects.For this part (91-6105x) and the previous one year (from the notification date), (b)(4).The most likely underlying cause could not be determined.It is possible that an insertion attempt was made off axis, the screws were inserted into high density bone, or were over-torqued.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.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: 1.5MM SYSTEM 1.65 X 5MM HIGH TORQUE SELF DRILLING CROSS DRIVE SCREW
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10101040
• Report Number: 0001032347-2020-00241
• Device Sequence Number: 19711512
• Product Code: JEY
• UDI-Device Identifier: 00841036134907
• UDI-Public: 00841036134907
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6105X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1