MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 9X20MM ROUND HD; 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	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): foreign: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.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
It was reported the screw broke while during the surgery.Another gt screw was used to complete the procedure.No additional consequences reported.

• Brand Name: GENTLE THREAD 9X20MM ROUND HD
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12100838
• Report Number: 0001825034-2021-01944
• Device Sequence Number: 17038428
• Product Code: HWC
• UDI-Device Identifier: 00880304007192
• UDI-Public: (01)00880304007192(17)220926(10)404620
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K982497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 09/26/2022
• Device Model Number: N/A
• Device Catalogue Number: 905616
• Device Lot Number: 404620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/01/2021
• 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