MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED DRILL CANNULATED SHORT 4.9 MM; DRILL, BIT

Catalog Number	00249006450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: guide wire gripper cat# 00249001200 lot# 65021987; uide pin sleeve short 3.0 mm cat# 00249006330 lot# 63267167; antegrade femoral connecting bolt small cat# 00249000801 lot# 62725440; impaction head cat# 00249003200 lot# 65105342; antegrade femoral targeting guide system screw cannula short 8.0 mm i.D.Cat# 00249008180 lot# 63317881.G2: south africa.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a drill bit tip was fractured during a procedure.There was no harm to patient or foreign bodies retained.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D1: zimmer natural nail system calibrated drill cannulated short 4.9mm.H6: proposed annex g code: mechanical (g04) - drill.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.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 is available at the time of this report.

• Brand Name: CALIBRATED DRILL CANNULATED SHORT 4.9 MM
• Common Device Name: DRILL, BIT
• 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: 18586195
• Report Number: 0001822565-2024-00237
• Device Sequence Number: 12891011
• Product Code: HTW
• UDI-Device Identifier: 00889024064256
• UDI-Public: (01)00889024064256(10)64922588
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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 Catalogue Number: 00249006450
• Device Lot Number: 64922588
• Was Device Available for Evaluation?: No
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown