MAUDE Adverse Event Report: BIOMET MICROFIXATION DRILL 1.5X105MM 22MM STP J-NT; FLUTED SURGICAL DRILL BIT, REUSABLE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #01-9198, lot # 347549, drill 1.5x105mm 22mm stp j-nt; item #01-9198, lot # 184901, drill 1.5x105mm 22mm stp j-nt; item #01-9198, lot # 357719, drill 1.5x105mm 22mm stp j-nt.Report source: (b)(6).Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00605, 0001032347-2021-00606, 0001032347-2021-00607.
Event or Problem Description
It is reported that the drill has broken.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Suggested imdrf code- mechanical (g04) - drill.Visual inspection of returned items show that the drill bits have fractured in the shaft of the drill bit area toward the collar area end.The remainder of the drill bit was not returned.No other information can be determined from returned product.Medical records were not provided.Review of the device history record(s) for item# 01-9198 lot# 347549 identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Suggested imdrf code- mechanical (g04) - drill.Two of item# 01-9198 lot# 347549 and one of item# 01-9198 lot# 184901 were returned.For item# 01-9198 lot# 357719 no product was not returned.Visual inspection of returned items show that the drill bits have fractured in the shaft of the drill bit area toward the collar area end.The remainder of the drill bit was not returned.No other information can be determined from returned product.Medical records were not provided.Review of the device history record(s) for item# 01-9198 lot# 347549 identified no deviations or anomalies during manufacturing related to the reported event.Review of the device history record(s) for item# 01-9198 lot# 184901 identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is alleged that the doctor did not use the product properly.However, no additional information was received and this cannot be 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.

• Brand Name: DRILL 1.5X105MM 22MM STP J-NT
• Common Device Name: FLUTED SURGICAL DRILL BIT, REUSABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13093484
• Report Number: 0001032347-2021-00604
• Device Sequence Number: 14501144
• Product Code: HBE
• UDI-Device Identifier: 00841036016982
• UDI-Public: (01)00841036016982(10)347549
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2022

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: 01-9198
• Device Lot Number: 347549
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 06/16/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/06/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Unknown