MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN 4.0MM #2 ETH *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222140

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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 expiration date is unknown.

Event Description

It was reported by the sales rep via cst that during an unknown procedure, the doctor could not get any torque when attempting to insert the 4mm fastin anchor into the patient.The case was completed with a different type of implant with no patient harm or delay.The implant was discarded.

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.The complaint device is not being returned, it was discarded by the customer, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformance were identified for this part (222140) - lot number (3908374) combination as per qlik query executed 04/12/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.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 with which this complaint is observed in the field.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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8475968
• MDR Text Key: 145911554
• Report Number: 1221934-2019-56741
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705007509
• UDI-Public: 10886705007509
• Combination Product (y/n): N
• PMA/PMN Number: K945203
• 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: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 222140
• Device Lot Number: 3908374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Patient Sequence Number: 1