MAUDE Adverse Event Report: ZIMMER BIOMET GENTLE THREADS INTERFERENCE SCREW ROUND HEAD 7X20MM; SCREW, FIXATION

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part#: 905629 lot#: 625450.Manufacture date: october 19, 2017.Sterile expiry date: october 19, 2022.Customer has indicated that 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.Multiple mdr reports were submitted for this event, please reference the following report numbers: 0001825034-2018 -04489, 0001825034 -2018-04520, 0001825034 -2018-04521, 0001825034-2018-04522, 0001825034-2018-04524, 0001825034 -2018 -04525, 0001825034-2018-04526, 0001825034-2018-04534, 0001825034-2018- 04536, 0001825034-2018-04537.
Event or Problem Description
It was reported that during an acl reconstruction procedure, it was discovered that the product inside was not the correct product and did not match the product id on the outer label.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of the pictures of the products sent.The box and inner packaging do not have the same item & lot numbers on the labels.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to manufacturing deficiency related to production & process control.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 THREADS INTERFERENCE SCREW ROUND HEAD 7X20MM
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET; 56 e. bell dr.; warsaw IN 46582
• MDR Report Key: 7679677
• Report Number: 0001825034-2018-04534
• Device Sequence Number: 10974870
• Product Code: HWC
• UDI-Device Identifier: 00880304008526
• UDI-Public: (01)00880304008526
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 01/23/2019

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: 10/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 905612
• Device Lot Number: 611330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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: Z-3176-2018, Z-3177-2018
• Patient Sequence Number: 1