MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5MM ETHIBOND W/O NDL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222723
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional 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).
Event or Problem Description
It was reported by the affiliate that during the surgical treatment of an ankle instability, the fastin 5.0 fastin anchor with green and white ethibond without needles cannot be fixed.This anchor was removed and a new one was used to complete the surgery.There were no adverse consequences to the patient.The surgery time was not delayed.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the device was received and visually inspected.The tyvek packaging, tray and inserter were the only things that were returned.Since the anchor was not returned, we cannot determine why it could not be inserted or seated.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on 5/24/2019.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.Udi: (b)(4).

• Brand Name: FASTIN RC 5MM ETHIBOND W/O NDL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8714586
• Report Number: 1221934-2019-57373
• Device Sequence Number: 11201616
• Product Code: HWC
• UDI-Device Identifier: 10886705008254
• UDI-Public: 10886705008254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 222723
• Device Lot Number: L862971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/20/2019
• Patient Sequence Number: 1