MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05603 and 0001822565-2019-05330.Product has been received by zimmer biomet and 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 that during a knee procedure, a drill pin was cross-threaded in a cut guide and became stuck.It could not be removed from the cutting block.No adverse events have been reported as a result of the malfunction.
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.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned tibial cut guide found signs of repeated use (nicked/ gouged) and burrs and an unknown pin is jammed in the guide.Device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the returned device indicates heavy usage, however as the number of times the device has been used is unknown, a definitive root cause cannot 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.

• Brand Name: TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9481243
• Report Number: 0001825034-2019-05603
• Device Sequence Number: 459634
• Product Code: HTJ
• UDI-Device Identifier: 00880304809093
• UDI-Public: (01)00880304809093(10)63777123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 42539905285
• Device Lot Number: 63777123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 05/28/2020
• 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