MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.9MM HEALX ADV SP PEEK ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222423
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer 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 sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the tip on the 4.9mm healx adv sp peek anchor device broke during insertion.All fragments were removed.Another like device was used to complete the procedure without delay.There were no adverse patient consequences 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.H10 additional narrative: investigation summary: according to the information received, the tip of the 4.9mm healx adv sp peek anchor was broken during insertion.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual analysis of the returned device, determined that the anchor was broken.In addition, the suture was breakage and frayed.In other hand, the anchor didn¿t present any evidence of debris.A manufacturing record evaluation was performed for the finished device lot number: 6l32121, and no non-conformances were identified.The compliant can be confirmed.Based on the information currently available.Product evaluation of the returned device indicates that this failure could be related with off axis insertion or levering during insertion.For the damage on the suture can be associated to an excessive tensioning on the procedure.As per ifu- 116478, indicate the instructions for user to handle the device at the insertion phase.In this case, it can be concluded that root cause of the failure reported is due to handling of the device, however; it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.
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: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: 4.9MM HEALX ADV SP PEEK ANCHOR
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11344646
• Report Number: 1221934-2021-00579
• Device Sequence Number: 3347559
• Product Code: MBI
• UDI-Device Identifier: 10886705030583
• UDI-Public: 10886705030583
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2021

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: 10/31/2022
• Device Model Number: 222423
• Device Catalogue Number: 222423
• Device Lot Number: 6L32121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/25/2021; 03/23/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 02/26/2021; 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1