MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROFIX QA+#3/0 OC V-4; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212859

Device Problems Device Damaged Prior to Use (2284); Material Integrity Problem (2978)

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: the device was received and evaluated.Upon visual inspection, it was observed that the anchor is deformed.A manufacturing record evaluation was performed for the finished device 8l44813 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.Multiple factors are associated with this type of failure, the device should be physically evaluated to determine a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by the distributor in (b)(4) that during incoming goods inspection, it was observed that that microfix qa+#3/0 oc v-4 anchor device was deformed.During in-house engineering evaluation, it was determined that the anchor device was deformed.There was no procedure nor patient involvement reported.No additional information could be provided.

• Brand Name: MICROFIX QA+#3/0 OC V-4
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14278988
• MDR Text Key: 290936476
• Report Number: 1221934-2022-01257
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705002481
• UDI-Public: 10886705002481
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 212859
• Device Catalogue Number: 212859
• Device Lot Number: 8L44813
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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 Age: 16 YR
• Patient Sex: Male
• Patient Weight: 62 KG