MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.75 HEALIX ADVANCE KNTLS PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	222584
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that prior to a patellar tendon repair procedure, it was noted that upon opening the 4.75 healix advance knotless peek device, a 4.5 healix advance medial row anchor was found in the packaging.The surgery was resolved by passing threaded suture through beath pin.It was reported that there was a two-minute delay to the surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
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.H10 additional narrative: h4: the device manufacture date was unavailable in the initial medwatch report.The device manufacture date had been identified and updated accordingly.
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.H10 additional narrative: investigation summary.The product has not returned to depuy synthes mitek, however photos were provided for review.The photo investigation revealed that 4.75 healix advance kntls peek box with lot number and lot number was visible.Also, an anchor was shown without original packaging.No other anomalies could be observed.The overall complaint was unconfirmed as the observed condition of the 4.75 healix advance kntls peek would not contribute to the complained device issue.The manufacturer performed an investigation of the photos provided with the following results: the part is not in the packaging tray and without the red threader and ring.An in-progress control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also per tm.The result of this process check is successful, none of the 9 parts were non-conforming.The batches have been assembled by operators trained and certified on the process validated in production.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Effect of having a 4.5 helix advance medial row anchor in the packaging for product code 222584 has been evaluated by combining probability and severity levels.1 complaint (this complaint) has been received over 7797 parts produced since 2018 for having a 4.5 helix advance medial row anchor in the packaging.With a ratio of 0.012% < 0.02% and is ranking 1(=improbable and negligible), this risk is acceptable.0 nr were found during search between 2018-2024 with the item reference (b)(4) nr for the same defect.The analysis showed that the production controls implemented must guarantee 100% detection of this type of problem if it was generated in neuchâtel.Multiple 100% control, guarantee that this type of defect does not occur in the manufacturing process.It can be concluded that it is highly unlikely that these defects were generated during the manufacturing process.Multiple controls 100% and in-process control ensures that manufactured products meet design specifications.Based on the above, it is confirmed that the manufacturing process was performed in accordance with the validated process.Device history record review: a device history record review was performed which indicated that there was a non-conformance unrelated to the reported malfunction.All the issues identified were resolved prior to product release.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: 4.75 HEALIX ADVANCE KNTLS PEEK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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: 19023810
• Report Number: 1221934-2024-01048
• Device Sequence Number: 18140952
• Product Code: MBI
• UDI-Device Identifier: 10886705030330
• UDI-Public: 10886705030330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2024

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 Catalogue Number: 222584
• Device Lot Number: 247L422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 04/18/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/15/2024; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• 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