MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 6.5 W/OCORD W/NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222992

Device Problem Material Deformation (2976)

Patient Problem Not Applicable (3189)

Event Date 01/01/2020

Event Type  malfunction  

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 employee via complaint submission tool that during triceps repair, the fastin rc 6.5 w/ocord w/ndls stripped off the anchor before anchor was fully inserted, a second implant was opened to utilize the inserter to continue driving the implant, the inserter stripped again, a third implant was opened and then try with the inserter, the anchor was explanted and another implant was inserted.No patient consequences, there was a surgical delay of 30 minutes reported.The device is not available to be returned for evaluation.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 (5l29708), 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 (5l29708), and no non-conformances were identified.

• Brand Name: FASTIN RC 6.5 W/OCORD W/NDLS
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9854224
• MDR Text Key: 201708999
• Report Number: 1221934-2020-00911
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705008704
• UDI-Public: 10886705008704
• Combination Product (y/n): N
• PMA/PMN Number: K060664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 222992
• Device Catalogue Number: 222992
• Device Lot Number: 5L29708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Patient Sequence Number: 1