MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL DRILL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tibia peg drill bound up in the tibial plate, producing metal shavings.There is no additional information available.
Additional Manufacturer Narrative
Medical product: size d left medial tibial provisional item# 42538100401 lot# 64690747.Articular surface inserter tip item# 42529900301 lot# 65261569.Headed screw 27 mm length item# 00598304027 lot# 65308058.Headed screw 27 mm length item# 00598304027 lot# 64744186.Headed screw 48 mm length item# 00598304048 lot# 65308108.Headless trocar drill pin 3.2 mm diameter 75 mm length item# 00590102000 lot# 65336216.Partial femur cemented size 5 left medial item# 42558000501 lot# 65215930.Partial articular surface left medial size d 8 mm thickness item# 42518200408 lot# 64660795.Partial tibial cemented size d left medial item# 42538000401 lot# 64805141.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product identified signs of use (striations).Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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.Component code: proposed component (annex g) code is mechanical (g04) - drill.

• Brand Name: TIBIAL DRILL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15141979
• Report Number: 0001825034-2022-01746
• Device Sequence Number: 5615079
• Product Code: HSX
• UDI-Device Identifier: 00889024582880
• UDI-Public: (01)00889024582880(10)64719750
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K200151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 42539904900
• Device Lot Number: 64719750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Patient Sex: Male