MAUDE Adverse Event Report: BIOMET MICROFIXATION ZDRIVE HIGH TORQUE DRIVER; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The devices will not be returned for investigation as the devices were discarded by the hospital.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Medical product: unk sternalock blu plate, part# unk, lot# unk.Unk screws, part# unk, lot# unk.
Event or Problem Description
It was reported that a high torque driver slowed down and sheared a screw in half while attempting to fixate a plate to the patient's sternum.The surgeon attempted to insert another screw with another driver and the same issue occurred again.The surgeon was able to remove the tips of the screws from the patient's bone.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is that the z-drive slowed down then sheared two screws in half.Three attempts were made for product return.No product was returned and no functional tests or inspections could be performed.For these reasons, the complaint could not be verified.The complaint history and dhr of this part could not be reviewed due to the lot numbers remaining unknown.The most likely underlying cause of the complaint could not be determined.There are no indications of manufacturing defects.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 or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
Field g4 date received by manufacturer was inaccurate on the initial medwatch report 0001032347-2019-00399.The originally reported value was aug 2, 2019.The correct value is aug 1, 2019.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: ZDRIVE HIGH TORQUE DRIVER
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8960948
• Report Number: 0001032347-2019-00399
• Device Sequence Number: 16728651
• Product Code: GEY
• UDI-Device Identifier: 00841036228514
• UDI-Public: 0841036228514
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 10/31/2019

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: 70-2001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 10/18/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/31/2019; 10/31/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention