MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5 HLX ADV PK 2.5 DYNAT WHT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	280717
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.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 sales rep that during an arthroscopic rotator cuff repair procedure on an unknown date, it was observed that the tip on the anchor on the 4.5 hlx adv pk 2.5 dynat wht device was cracked.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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.Device was used for treatment, not diagnosis.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 mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the device was not received in its entire packaging.It could be observed that the anchor had a crack near the distal part; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number and no non conformances were identified.A manufacturing investigation was performed, as a result, the process of the healix have phases where check the condition of the anchor, during the assembling anchor/suture, assembling anchor/suture/shaft, finals controls of the assembling products, inspection station pouch.Based on the condition of the device received, the root cause for the issue experienced by the customer could not be established.The possible root cause could be attributed to the handling of the device and anchor interaction at the moment of open the packaging.However, it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.A further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: 4.5 HLX ADV PK 2.5 DYNAT WHT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15297074
• Report Number: 1221934-2022-02577
• Device Sequence Number: 6276547
• Product Code: MAI
• UDI-Device Identifier: 10886705031047
• UDI-Public: 10886705031047
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 01/31/2025
• Device Model Number: 280717
• Device Catalogue Number: 280717
• Device Lot Number: 8L94691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 11/24/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 08/30/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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