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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source: france.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
It was reported that in a surgery, during the insertion of a pertrochanteric nail, at the end of the procedure, the distal end of the drill was found to be broken.The missing fragments were not present in the ancillary box and were not recovered/searched, as the breakage was not felt by the operator.No clinical consequences were observed.Due diligence is in process and to date no additional information on the reported event has been provided.
Event or Problem Description
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: a1, a2, a3, a4, b4, b7, e1, e3, g3, g6, h2, h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10.Freehand targeting drill 4.3 mm diameter item# 00249007243 lot# 62641346.Freehand targeting drill 4.3 mm diameter item# 00249007243 lot# 66283054.Cephalomedullary lag screw stop assembly item# 00249000345 lot# unknown.Cmn femoral nail, ccd 125â°, left, 㸠11.5 mm, 30 cm item# 47249330111 lot# 3172533.Z nail 10.5 x 110 lag screw item# 47248511010 lot# 3191905.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head item# 47248403250 lot# 66640486.Two lag screw reamers were returned for investigation along with two freehand targeting drill and one cm lag screw stop assembly to the product surveillance team for examination.The shafts of the lag screw reamers show signs of normal usage, but it is overall inconspicuous.The cutting edges of the instruments are fractured.No fragments were returned.Both freehand targeting drills as well as the cm lag screw stop assembly are inconspicuous with normal signs of wear.Of note, it is not possible to distinguish which lag screw reamer belongs to this complaint, as both lag screw reamers were returned to the product surveillance team together and both lag screw reamers have the same lot number.Both lag screw reamers were handled by the same surgeon with different event dates.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.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.Medical records were not provided.Based on the analysis of the returned instrument, a fracture of the lag screw reamer 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 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.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: ZNN¿¢, CMN LAG SCREW REAMER, SHORT
• Common Device Name: INSTRUMENT, TRAUMA
• 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: 20292104
• Report Number: 0009613350-2024-00464
• Device Sequence Number: 20654052
• Product Code: HAW
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(10)4505035466
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 01/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249000364
• Device Lot Number: 4505035466
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 01/13/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/18/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 40 KG