MAUDE Adverse Event Report: ZIMMER GMBH NCB®, DRILL BIT, ø 4.3 MM, 195 MM; TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the piece was found broken in the kit prior to the surgery.There is no reported patient involvement.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: ncbâ®, drill guide, 㸠4.3 mm item 0200024011 lot 4504435489.G2: foreign: spain.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was returned to product surveillance team for examination.Visual inspection of the drill bit shows a fracture at the cutting area.The broken piece was not returned.The fracture of the instrument can therefore be confirmed.The fracture surface of the drill bit is damaged.Furthermore, several marks are visible on the drill bit.It can be assumed that the drill bit was used several times in surgeries.A review of all relevant device manufacturing records and raw material certificate confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information at this time.

• Brand Name: NCB®, DRILL BIT, ø 4.3 MM, 195 MM
• Common Device Name: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18815667
• Report Number: 0009613350-2024-00073
• Device Sequence Number: 19913312
• Product Code: HWC
• UDI-Device Identifier: 00889024289260
• UDI-Public: (01)00889024289260(11)170313(10)4501655845
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup
• Report Date (Section B): 07/25/2024

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 Model Number: N/A
• Device Catalogue Number: 0200024002
• Device Lot Number: 4501655845
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 04/24/2024; 07/22/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/09/2024; 05/08/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2017
• 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 Sex: Unknown