MAUDE Adverse Event Report: APERFIXII CANN TIBIAL 10X30MM; SCREW, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned for analysis and an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during surgery, the guide wire was inserted and the tibial sheath was inserted of the guide wire.The screw was inserted over the guide wire and as the screw was being tightened, the sheath busted.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the returned product identified the product was returned with several pieces including a poly screw, fractured poly sheath, and a smaller white handled tool.None of the products are etched with part or lot numbers for identification.The larger, blue handled inserter shows no signs of damage and the hex feature appears intact.The smaller, white handled inserter shows no signs of damage and appears completely intact.The screw has flaring in several areas along the threads and the tip appears worn down/ deformed.The sheath is split into two (2) pieces.The sheath has a slight bend to the body and several deformities along the edges.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to 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: APERFIXII CANN TIBIAL 10X30MM
• Common Device Name: SCREW, FIXATION
• MDR Report Key: 12638572
• Report Number: 3006108336-2021-00044
• Device Sequence Number: 17213909
• Product Code: HWC
• UDI-Device Identifier: 00887868269707
• UDI-Public: (01)00887868269707(17)250828(10)77242-2
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083607
• 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): 10/29/2021

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 Expiration Date: 08/28/2025
• Device Model Number: N/A
• Device Catalogue Number: CM-3010C
• Device Lot Number: 77242-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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
• 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