MAUDE Adverse Event Report: ZIMMER GMBH DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Product information was provided for the following screws; however, it is unknown which one interfered with the drill bit: ncb screw 5.0 l = 16, item #: 02.02150.016, lot #: 3054220 qty:1.Ncb screw 5.0 l = 30, item #: 02.02150.030, lot #: 3169138 qty:1.Ncb screw 5.0 l = 32, item #: 02.02150.032, lot #: 3158637 qty:1.Ncb screw 5.0 l = 36, item #: 02.02150.036, lot #: 3169095 qty:1.Ncb screw 5.0 l = 46, item #: 02.02150.046, lot #: 3172390 qty:1.Ncb screw 5.0 l = 55, item #: 02.02150.055, lot #: 3169900 qty:1.Ncb clamp-screw, item #: 02.02150.300, lot #: 3174954, qty:2.Ncb clamp-screw, item #: 02.02150.300, lot #: 3186326, qty:2.Ncb clamp-screw, item #: 02.02150.300, lot #: 3186328, qty:1.Ncb clamp-screw, item #: 02.02150.300, lot #: 3187098, qty:1.Ncb clamp-screw, item #: 02.02150.300, lot #: 3191501, qty:3.Ncb clamp-screw, item #: 02.02150.300, lot #: 3191502, qty:2.Ncb canc screw 5.0 32mm l80, item #: 02.02152.080, lot #: 3160683, qty:1.Ncb canc screw 5.0 32mm l85, item #: 02.02152.085, lot #: 3181233, qty:2.Ncb canc screw 5.0 32mm l90, item #: 02.02152.090, lot #: 3137811, qty:1.Ncb canc screw 5.0 32mm l90, item #: 02.02152.090, lot #: 3191510, qty:1.Ncb canc scr 5.0 32mm l95mm, item #: 02.02152.095, lot #: 3125131, qty:1.Ncb pp dis fem plt l12h l278mm, item #: 02.02264.112 lot #: 3197900 qty:1.G2.Report source: japan.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 initial operation was performed with ncb pp system.After several screws were inserted, the drill broke due to interference with an already inserted screw when a new screw hole was being drilled.The broken drill tip could not be extracted and remained in the patient's body.Reoperation is not planned.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The drill was returned for examination.The event can be confirmed as the drill si fractured in the cutting area.The shaft of the instrument is inconspicuous.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Based on the available information, the reported event can be confirmed.The instrument was manufactured in 2014 and is used with high torque forces.Therefore, the event reported is most likely attributed to wear and tear from repeated use over almost 10 years of field life.Moreover, it was reported that according to the doctor, the drill broke because it interfered with a screw that had already been inserted.However, with the available information a definitive root cause cannot be established.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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM
• Common Device Name: INSTRUMENT, HIP
• 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: 19829006
• Report Number: 0009613350-2024-00308
• Device Sequence Number: 8102806
• Product Code: HRX
• UDI-Device Identifier: 00889024298064
• UDI-Public: (01)00889024298064(11)140904(10)14023537
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10325180
• Device Lot Number: 14023537
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2014
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown