MAUDE Adverse Event Report: BIOMET UK LTD. TIBIAL RESEC HEAD-LEFT W/ALIG; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide.It was determined that it was the cut block that was the issue as the right block threaded on just fine.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6.It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide.It was determined that it was the cut block that was the issue as the right block threaded on just fine.Visual inspection confirmed the reported event.The component will not assembly with its matting instrument by using the thread which is damaged.Metal pick up is observed on the damaged 3rd and 4th threads.The root cause of the reported event could not be determined with the information provided in the complaint.The mating instrument has not been returned with the damaged component to confirm whether it is what damaged the reported event.Device history record (dhr) was reviewed and no discrepancies were found.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
Instrument would not assemble onto mating instrument.

• Brand Name: TIBIAL RESEC HEAD-LEFT W/ALIG
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8944149
• Report Number: 3002806535-2019-00710
• Device Sequence Number: 11380238
• Product Code: HTJ
• UDI-Device Identifier: 00880304434752
• UDI-Public: 00880304434752
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 32-487556
• Device Lot Number: ZB151102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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