MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.5HLX ADV PK ANC-DYNA 3-SUT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	222029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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 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.H11 additional narrative: investigation summary the product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that the device is shown in used condition.The anchor was found cracked in the middle.Biological matter can be observed over the shaft.The overall complaint was confirmed as the observed condition of the 4.5hlx adv pk anc-dyna 3-sut would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment may occurred and consequently the anchor was damaged.As per ifu, inserting the awl or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.Do not apply a bending force to the inserter.This can damage the anchor or inserter tip.It has been determined that no corrective and/or preventative action is required.As part of depuy synthes 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.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.
Event or Problem Description
It was reported that during a rotator cuff repair procedure, it was discovered that the 4.5mm healix advance peek anchor with dynacord suture device broke immediately, even though it was inserted correctly.It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery.There was patient involvement reported.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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and 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.H11 additional narrative: investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition.The anchor was found broken in the middle.The overall complaint was confirmed as the observed condition of the 4.5hlx adv pk anc-dyna 3-sut would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment may occurred and consequently the anchor was damaged.As per ifu, inserting the awl or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.Do not apply a bending force to the inserter.This can damage the anchor or inserter tip.It has been determined that no corrective and/or preventative action is required.As part of depuy synthes 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.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.

• Brand Name: 4.5HLX ADV PK ANC-DYNA 3-SUT
• 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: 20075745
• Report Number: 1221934-2024-02956
• Device Sequence Number: 3200214
• Product Code: MBI
• UDI-Device Identifier: 10886705029419
• UDI-Public: (01)10886705029419(10)TMXALT(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• 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): 08/27/2024

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: 222029
• Device Lot Number: TMXALT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 09/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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