MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate the complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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 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).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during a rotator cuff procedure the 4.75 healix advanced knotless peek anchor broke.The case was completed using a like device and no new bone hole was needed.There was no patient consequence or delay in surgery.This is report 1 of 1 for (b)(4).
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate correction: no nonconformances were identified for this product code and lot number combination.

• Brand Name: 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8285082
• Report Number: 1221934-2019-56208
• Device Sequence Number: 13874525
• Product Code: MBI
• UDI-Device Identifier: 10886705023455
• UDI-Public: 10886705023455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130539
• 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): 03/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 222333
• Device Lot Number: 3918259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1