MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222334
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
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.(b)(4).
Event or Problem Description
It was reported by the sales rep that the customer's 5.5 healix advance knotless anchor cracked at the distill tip during a rotator cuff repair.The case was completed with another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device is being returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device has been received and evaluated.Visual observation revealed a crack on the distal tip of the anchor, confirming the complaint.Suture card and suture were both intact, and looked to be unused.The anchor was easily removed from the shaft with no difficulty.No anomalies were found that could have caused the reported failure.There were two cracks visible on the anchor both parallel to each other.The cracks ran vertically from the distal tip to the second thread of the anchor, indicating the anchor fractured during initial insertion in the bone hole.The possible root causes for the user to experience this type of failure could be off axis insertion, levering during insertion, using incorrect instrumentation for preparing bone hole, or slight small bone hole preparation.This failure could be attributed to user technique.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review of the depuy synthes mitek complaints system no other complaints of any type for this lot of devices that were released to distribution.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 to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7434367
• Report Number: 1221934-2018-50471
• Device Sequence Number: 1716487
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 04/30/2020
• Device Catalogue Number: 222334
• Device Lot Number: L374700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1