MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX DT PEEK ANC.W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).That was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is broken.Visual inspection under magnification reveals that the threads were not worn.It was reported that the anchor broke while the surgeon was trying to insert the anchor.It is possible that the anchor broke while the surgeon was ziplining the anchor into the bone hole.When excessive tension is applied to the suture while ziplining the anchor it has the potential to cause the distal tip breakage, therefore is a potential root cause for the reported failure.A non-conformance search was performed for this part,lot combination and no non-conformances were identified.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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a hip procedure the peak anchor broke while they were trying to implant it.All the pieces were retrieved from the patient and another anchor, same product code and lot number, was used to complete the case.The sales rep reported no patient harm or time delay to the case.

• Brand Name: 5.5 HEALIX DT PEEK ANC.W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8353724
• Report Number: 1221934-2019-56443
• Device Sequence Number: 1697717
• Product Code: MAI
• UDI-Device Identifier: 10886705007585
• UDI-Public: 10886705007585
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 222210
• Device Lot Number: L909491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1