MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN¿, CMN LAG SCREW, Ø 10.5 MM, 95 MM INCLUDING SET SCREW; TRAUMA PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: unknown guide wire, item#: unknown, lot#: unknown.Report source: foreign ¿ canada.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2023-00069.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 the surgeon experienced resistance when attempting to slide the lag screw over the guidewire.The guide wire was pushed into patient's pelvis, but a ct scan completed the day after surgery did not reveal any abdominal or pelvic injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b3, b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.No products was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for item.47-2485-095-10 lot.3112405 identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: ZNN¿, CMN LAG SCREW, Ø 10.5 MM, 95 MM INCLUDING SET SCREW
• Common Device Name: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16406736
• Report Number: 0009613350-2023-00068
• Device Sequence Number: 5759336
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: (01)00889024298446(17)270610(10)3112405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• 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): 04/05/2023

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: 47-2485-095-10
• Device Lot Number: 3112405
• Was Device Available for Evaluation?: No
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose