MAUDE Adverse Event Report: ZIMMER BIOMET, INC. T7 DRIVER CANN AO

Model Number	110018531
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the device bent during use with no consequences to the patient.It should be noted the surgeon was aware the device was recalled and continued its use.No further information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review.The product certification was reviewed and no discrepancies were identified, but the device history records were not reviewed as the device was recalled.As the surgeon utilized the device with the knowledge that the device had been recalled, the root cause is attributed to user error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: T7 DRIVER CANN AO
• Common Device Name: DRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9501521
• Report Number: 0001825034-2019-05611
• Device Sequence Number: 13838343
• Product Code: HWC
• UDI-Device Identifier: 00887868138553
• UDI-Public: 00887868138553
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 110018531
• Device Catalogue Number: 110018531
• Device Lot Number: 15167A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 06/05/2020
• 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: Z-1302-2019
• Patient Sequence Number: 1