MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX TI 3SUTURE ANC W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222271
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that a hair-like foreign body was found in the vacuum package of the 4.5 healix ti 3suture anc w/oc device.There was no procedure nor patient involvement reported.No additional information was 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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Investigation summary: the product was returned to us cq for evaluation and images of the received products were provided to jnj neuchatel site for evaluation.Visual analysis of the returned sample revealed that the hair is present between outer shrink wrap and outside package.The product is out of its original box from the johnson neuchatel site.The packaging has been handled outside the neuchatel site since labels (which are not from the neuchatel site) have been glued on the outer package.The dimensional inspection was not performed as it's not pertaining to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed 4.5 healix ti 3suture anc w/oc.No definitive root cause can be established as it can be confirmed that the complaint condition did not happened at johnson neuchatel site.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: product code: 222271; lot number: 6l84339; manufacturing date: 31-mar-2020; expiry date: 28-feb-2023; quantity: (b)(4) each; release date: 17-apr-2020.There was no non conformance regarding this lot.

• Brand Name: 4.5 HEALIX TI 3SUTURE ANC W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12659199
• Report Number: 1221934-2021-03060
• Device Sequence Number: 4211412
• Product Code: HWC
• UDI-Device Identifier: 10886705008162
• UDI-Public: 10886705008162
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2021

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: 02/28/2023
• Device Model Number: 222271
• Device Catalogue Number: 222271
• Device Lot Number: 6L84339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 01/05/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/16/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown