MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA

Model Number	00-2490-032-44
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source foreign: canada.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 mdr will be submitted.
Event or Problem Description
It was reported that while the surgeon was using the instrument to ream the patient's femoral head, the tip of the instrument fractured inside the patient's femoral head.The surgeon was able to remove the tip of the instrument from the patient's bone.The surgeon was able to continue the surgery with no additional complications.No additional information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional/corrected information.H6: component codes: mechanical (g04) - drill.Visual examination of the returned product identified the end of the cutting feature has fractured and the cutting edges are dull and damaged.Wear and tear is seen that indicates repeated use during a potential field age greater than 3 years.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16714449
• Report Number: 0001822565-2023-00994
• Device Sequence Number: 15246814
• Product Code: HSB
• UDI-Device Identifier: 00889024063532
• UDI-Public: (01)00889024063532(10)64657022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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: 00-2490-032-44
• Device Catalogue Number: 00249003244
• Device Lot Number: 64657022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 07/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/31/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2020
• 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: 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 170 KG