MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 9X30MM FULL THRD; 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	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - (b)(6).The product has been received by zimmer biomet and the investigation results are as follows: visual examination of the returned product identified the tip has fractured and all the pieces were returned.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after 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
It was reported that the interference screw was broken while fixing.Attempts have been made, but no further information is available at the time of this report.

• Brand Name: GENTLE THREAD 9X30MM FULL THRD
• Common Device Name: SCREW- FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12068819
• Report Number: 0001825034-2021-01881
• Device Sequence Number: 897828
• Product Code: HWC
• UDI-Device Identifier: 00880304006676
• UDI-Public: (01)00880304006676(17)240109(10)816440
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 01/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 905608
• Device Lot Number: 816440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/25/2021
• 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
• Patient Age: 27 YR