MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW REAMER, SHORT; TRAUMA, REAMER.

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
Event or Problem Description
It was reported that during the procedure the znn cmn hip screw drill bit broke off during use.Attempts have been made and no additional information on the reported event is required at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 00249000364, znnâ¿¢, cmn lag screw reamer, short, lot # 4504918744 g2: report source germany 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 further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The lag screw reamers were returned for investigation.The rear ends and the shafts of the reamers show signs of normal usage and are overall inconspicuous.The cutting edges of the instruments are damaged and the tips of both reamers are fractured off; the fragments were not returned.A review of the device manufacturing records confirmed no abnormalities or deviations.No information was received on the other instruments and implants used during surgery; therefore, a compatibility review of the involved products could not be verified.Surgical technique recommends to "assemble the lag screw trocar into the lag screw cannula and pass through the correct hole in the targeting guide for the chosen ccd angle" and suggest "hole indicators can be placed in static (st) and dynamic (dy) holes of the targeting guide and in holes for ccd angles that will not be used to avoid the occidental use of those holes during the surgery".Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Based on the analysis of the returned instruments, a fracture of the tip for both lag screw reamers can be confirmed.The review of the surgical technique suggests that using the wrong ccd angle during assembly of the lag screw reamer on the targeting guide could potentially lead to an impingement of the tip of the lag screw on the nail, which might contribute to the fracture of the reamer.However, with the available information, it is impossible to reproduce the reported event, and 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.

• Brand Name: ZNN¿¢, CMN LAG SCREW REAMER, SHORT
• Common Device Name: TRAUMA, REAMER.
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 20138045
• Report Number: 0009613350-2024-00425
• Device Sequence Number: 3186983
• Product Code: HSB
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(10)4504491713
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 00249000364
• Device Lot Number: 4504491713
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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 H11 NARRATIVE.
• Patient Sex: Unknown