MAUDE Adverse Event Report: ZIMMER GMBH AFFIXUS INSTRUMENTS; TRAUMA, GUIDE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source south africa 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 there was a damaged affixus humeral nail targeting guide during surgery.The tooth that stabilizes the targeting guide to not rotate around the nail is broken.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay corrected information, as the investigation summary was erroneously left out of the previous report.The following sections were updated/corrected: b4, h2, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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
No further event information available at the time of this report.

• Brand Name: AFFIXUS INSTRUMENTS
• Common Device Name: TRAUMA, GUIDE
• 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: 18181243
• Report Number: 0009613350-2023-00642
• Device Sequence Number: 18079213
• Product Code: HSB
• UDI-Device Identifier: 00889024506688
• UDI-Public: (01)00889024506688(10)4503289355
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K200814
• 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): 02/01/2024

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: 110035679
• Device Lot Number: 4503289355
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 01/16/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/31/2024; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HUMERUS NAIL.
• Patient Sex: Unknown