MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 9X35MM FULL THRD; SPORTSMED, IMPLANTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: event occurred in (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
Event or Problem Description
It was reported that the screw was broken while implanting.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: udi#:(b)(4).The following sections were updated/corrected updated: b4, b5, d4, d10, g4, g7, h2, h3, h6, h10.The event is confirmed with product received.Visual examination of the returned product identified the screw was returned because it fractured during insertion.Both ends of the screw are fractured.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: GENTLE THREAD 9X35MM FULL THRD
• Common Device Name: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10489267
• Report Number: 0001825034-2020-03210
• Device Sequence Number: 2567612
• Product Code: HWC
• UDI-Device Identifier: 00880304421042
• UDI-Public: (01)00880304421042
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 905627
• Device Lot Number: 968470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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: 28 YR