MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.75 HEALIX ADVANCE KNTLS PEEK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222584
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
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 a rotator cuff repair procedure on (b)(6) 2020, it was observed that the sutures of the 4.75 healix advance knotless peek device did not come through while pulling them.Another like device was used to complete the procedure without delay.There were no 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.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: according to the information received, it was reported that during a rotator cuff repair that the sutures of the 4.75 healix advance knotless peek did not come through while pulling them.The device was received and evaluated.Upon visual inspection, it was identified that the threader tab was damaged due to it was bent and the threaded wire was not attached through the distal part of the anchor.The cleats of the ring and the anchor were in good condition; also, the suture card was still in place.Since the condition of the device received, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: l918907, and no nonconformances were identified.Further, a review into the mitek complaints system revealed no other complaints for this lot of 300 devices that were released to distribution.No additional information regarding the technique used during the procedure was provided to determine the causes contributed to this event.We cannot discern a specific root cause.It is possible that the threaded wire was damaged when it was reloaded and pushing the wire under a high tension.As per ifu- 116000 it is necessary to keep the sutures at equivalent lengths after passing/ trying.When pull the threader tab, which is attached to the wire until all sutures have been pulled through the anchor, driver collar and out of the slot in the driver.To reload the threader tab, slide the driver collar to the distal end of the slot in the driver push the wire kite through the driver collar, into the slot of the driver.Feed the wire kite until it appears through the distal tip of the anchor.It is important to holding sutures under slight tension.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: 4.75 HEALIX ADVANCE KNTLS PEEK
• 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: 11087634
• Report Number: 1221934-2020-04106
• Device Sequence Number: 3561488
• Product Code: MBI
• UDI-Device Identifier: 10886705030330
• UDI-Public: 10886705030330
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

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: 05/31/2021
• Device Model Number: 222584
• Device Catalogue Number: 222584
• Device Lot Number: L918907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/25/2021; 02/01/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1