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

Catalog Number 222422

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair the permatape slipped out of the 4.9 mm healix adv sp biocomposite anchor after cutting the end.No patient consequences or surgical delay reported.The device is still implanted and is not available to be returned for evaluation.

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 provided, it was reported that during the procedure the permatape slipped out of the 4.9mm healx adv sp biocomposite anchor after cutting the end.The complaint device will not be returned since it was implanted, therefore unavailable for a physical evaluation.Since the complaint device was implanted, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [6l90240] number, 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.

• Brand Name: 4.9MM HEALX ADV SP BIOC ANCHOR
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10751907
• MDR Text Key: 213696229
• Report Number: 1221934-2020-03223
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K191242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 222422
• Device Lot Number: 6L90240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Patient Sequence Number: 1