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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical products: item# 91-6105, lot j935280: 1.5mm system high torque (ht),sd,x-dr,screw 1.5mm x 5mm.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00244.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.
Event or Problem Description
It was reported that during fixation of the bone flap, when fixing the plates with self-drilling screws, two heads of the screws were fractured.The plate was immediately changed in position and different screws were used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the two returned screws.Both screws show signs of attempted use including marking/ scratching on the screw head.Both screws have fractured where the screw head meets the screw shaft.The complaint is confirmed for both screws.A determination cannot be made as to what caused the screws to fracture.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause 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.This report is being submitted to update additional information in section b4, b5, d9, g3, g6, h2, h3, h4, h6 and h10.
Event or Problem Description
It was reported that during fixation of the bone flap, when fixing the plates with self-drilling screws, two heads of the screws were fractured.The plate was immediately changed in position and different screws were used to complete the procedure.It has been further reported that fragments of the broken screws remain implanted.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCREW 1.5MM X 5MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15146284
• Report Number: 0001032347-2022-00243
• Device Sequence Number: 5553606
• Product Code: JEY
• UDI-Device Identifier: 00841036219499
• UDI-Public: (01)00841036219499(10)J935280
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6105
• Device Lot Number: J935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Unknown