MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX3 PEEK ANC.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222207
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi: (b)(4).The expiration date is unknown at this time.
Event or Problem Description
This case is from health authority.It was reported that the physicians found the expire date on the inner package and outer package is different.It was found that the label on the built-in package has expired, while the outer package is within the validity period.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d4: the expiration date was reported as unknown on the initial report; and has been updated accordingly.Therefore, udi: (b)(4).Investigation summary = > the complaint device or package is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.It was reported that the label on the built-in package has expired, while the outer package is within the validity period.As per the manufacturer, the expiry date of the impacted product lot is 30th november 2022 which is within the validity period.A follow up for the pictures of the inner and outer packages were performed but we received response that the pictures are not available.With the information provided, and without the complaint device or package to evaluate, we cannot determine a root cause for the reported problem.A manufacturing record evaluation was performed for the finished device lot number (6l54762), and no non-conformance was identified.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 5.5 HEALIX3 PEEK ANC.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10549815
• Report Number: 1221934-2020-02652
• Device Sequence Number: 3032597
• Product Code: MAI
• UDI-Device Identifier: 10886705007554
• UDI-Public: 10886705007554
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 11/30/2022
• Device Model Number: 222207
• Device Catalogue Number: 222207
• Device Lot Number: 6L54762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Patient Age: 35 YR