MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 6X23; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 231807

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that during an unspecified surgical procedure on (b)(6) 2024, it was observed that the 6mm x 23mm milagro screw device anchor was broken off, removed all the broken parts.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: e1: the initial reporter's facility address was not provided.E3: reporter is a j&j sales representative.(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.

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 investigation has been updated to reflect the correct information: investigation summary according to the information provided, it was reported that ¿the anchor was broken off, removed all the broken part¿.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device 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 lot number (220l060), and no non-conformance was 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.Correction d4: the device expiration date was unknown in the initial report.The date of expiration has been updated accordingly.Correction h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.Udi: udi updated to (b)(4).

• Brand Name: MILAGRO INSCR SMALL SIZE 6X23
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 19039791
• MDR Text Key: 339322325
• Report Number: 1221934-2024-01091
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010752
• UDI-Public: 10886705010752
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 231807
• Device Lot Number: 220L060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1