MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LENGTHENED 1.3 MM SQUARE DRVR; DRIVER, PROSTHESIS

Catalog Number	SSI005302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is currently unknown whether the device will be returned for evaluation.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 specialized 1.3mm square driver broke in surgery.The 1.3mm tip of the driver broke.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.
Event or Problem Description
No additional information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The root cause of the reported issue is attributed to use error.Per the dvr anatomic volar plating system surgical technique, the green fully threaded screws are not compatible with the dvr volar plates; the breakage of the driver occurred while the surgeon was trying to insert these screws.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: LENGTHENED 1.3 MM SQUARE DRVR
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12954055
• Report Number: 0001822565-2021-03474
• Device Sequence Number: 14532336
• Product Code: HWR
• UDI-Device Identifier: 00889024578616
• UDI-Public: (01)00889024578616(11)11012021(10)97020128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2022

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 Catalogue Number: SSI005302
• Device Lot Number: 97020128
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 03/10/2022; 05/17/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 03/30/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Patient Sex: Unknown