MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM INSERTER CONNECTOR SHORT R SHORT; INSTRUMENT/TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical products: item#: 281001100, ball nose guide wire 100cm; lot#: 312560; item#: 47-2495-320-10, z nail tibia 10mm x 32cm univ; lot#: 65082488; item#: 47-2484-030-50, z nail 5.0x30 cort screw fa; lot#: 64875647; item#: 47-2484-040-50, z nail 5.0x40 cort screw fa; lot#: 65007886; item#: 47-2484-030-50, z nail 5.0x30 cort screw fa; lot#: 64890295; item#: 47-2484-047-50, z nail 5.0x47.5 cort screw fa; lot#: 65007874; item#: 47-2484-030-50, z nail 5.0x30 cort screw fa; lot#: 64875674.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a surgical procedure that while attempting to implant a distal screw the tip of the instrument fractured off and was unusable.There was no reported harm or injury to the patient.Attempts have been made and no additional event information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned product to verify item and lot number.Cosmetic inspection confirms the product has fractured at the tip and not all the pieces were returned.Review of the device history record identified no deviations or anomalies during manufacturing.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5MM INSERTER CONNECTOR SHORT R SHORT
• Common Device Name: INSTRUMENT/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12076752
• Report Number: 0001825034-2021-01894
• Device Sequence Number: 14453065
• Product Code: LXH
• UDI-Device Identifier: 00887868093746
• UDI-Public: (01)00887868093746(11)180611(10)ZB180502
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 14-441045
• Device Lot Number: ZB180502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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