MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHRT SM DRILL GUIDE 5 HOLE; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported upon drilling pilot holes for transverse pin, the drill became lodged in the guide and was unable to be removed.No patient harm.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.Unk drill bit lot# unk.Mdr: 0001825034-2022-02449.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned device found an unknown pin seized in one of the guide holes.Eight of the guide holes were found to be conforming one was found to be non-conforming as has burrs in the hole.The guide and pin exhibits signs of repeated use.Review of the device history records for the guide identified no related deviations or anomalies during manufacturing.Review of complaint history for the guide found no additional related issues for part search and the reported part and lot combination.No medical records were provided.This complaint is confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: CPS SHRT SM DRILL GUIDE 5 HOLE
• Common Device Name: INSTRUMENT, 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: 15699367
• Report Number: 0001825034-2022-02448
• Device Sequence Number: 8192966
• Product Code: FZX
• UDI-Device Identifier: 00887868488467
• UDI-Public: (01)00887868488467(11)180613(10)044120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 32-472711
• Device Lot Number: 044120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Male