MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5HLX ADV BR ANC-DYNA STR/BL; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Perforation of Vessels (2135)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.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 Description

It was reported by a healthcare professional through a clinical trial using 5.5hlx adv br anc-dyna str/bl device that a patient had neurovascular injury related to a biceps tenodesis procedure of the left shoulder that was performed on (b)(6) 2021.According to the report, the patient consequence was mild; and therefore, did not require a revision/reoperation procedure.The current status of the patient was unknown.No additional information was provided.

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 : the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through clinical research data.The clinical research data indicated depuy mitek product failure(s).Since there was no contact information, no follow-up attempts could be performed.It is unknown if complaints derived from this clinical research data were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.

• Brand Name: 5.5HLX ADV BR ANC-DYNA STR/BL
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13598878
• MDR Text Key: 286123528
• Report Number: 1221934-2022-00631
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705029464
• UDI-Public: 10886705029464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 222004
• Device Catalogue Number: 222004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female