MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.9MM HEALX ADV SP BIOC ANCHOR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222422

Device Problems Entrapment of Device (1212); Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the sales rep via phone that during a arthroscopic shoulder stabilization procedure shortly after the 4.9mm healix adv sp biocomposite anchor was inserted , the tape lost all tension.The physician was able to remove the suture from the cuff/anchor while the anchor remained in the bone.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device was discarded by the hospital.No replacement was requested.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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 discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l93076), and no non-conformances were identified.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 with which this complaint is observed in the field.Device history lot: a manufacturing record evaluation was performed for the finished device lot number (5l93076), and no non-conformances were identified.

• Brand Name: 4.9MM HEALX ADV SP BIOC ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9856912
• MDR Text Key: 188652051
• Report Number: 1221934-2020-00921
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705030576
• UDI-Public: 10886705030576
• Combination Product (y/n): N
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 222422
• Device Catalogue Number: 222422
• Device Lot Number: 5L93076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2020
• Patient Sequence Number: 1