MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.4MM SHORT DISP SET HORT DISP; FASTNER, FIXATION

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).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 report will be submitted.Product not returned.
Event or Problem Description
It was reported that during the surgery, the tip of the drill guide was deformed during use.Therefore, the surgeon used an alternative of the same guide to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the device appears to be cracked.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: JGRKNT 1.4MM SHORT DISP SET HORT DISP
• Common Device Name: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9336216
• Report Number: 0001825034-2019-05224
• Device Sequence Number: 1864790
• Product Code: MBI
• UDI-Device Identifier: 00880304858992
• UDI-Public: (01)00880304858992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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 Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 912073
• Device Lot Number: 319090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1