MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX 5.5MM PEEK W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
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.Evaluation statement: the complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is broken, but is held in place by suture confirming the failure.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.It is reported that the patient had hard bone quality which contributed for this failure.A device history record (dhr) review was conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.Our results indicate that this batch was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one similar complaint of any type for this lot of devices that were released to distribution.At this point in time, 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.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
The sales representative reported via phone that the customer's healix 5.5mm peek with orthocord broke upon insertion cracked at the first thread and was not going out.The sales representative stated that the patient had hard bone.The case was completed using another anchor with the same bone hole.There were no patient consequences or delays.The device is being returned for evaluation.

• Brand Name: HEALIX 5.5MM PEEK W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7781647
• Report Number: 1221934-2018-53224
• Device Sequence Number: 11201757
• Product Code: MAI
• UDI-Device Identifier: 10886705007578
• UDI-Public: 10886705007578
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 222209
• Device Lot Number: L165771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1