MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX PEEK 3.4 MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222344
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2013
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.Investigation summary: evaluation statement- the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been 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 of product was processed with an unrelated (non-conformance/out of tolerance) to the reported incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind 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.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.Device history lot: the batch review 3711039 showed that the devices were conformed to in process and finished goods specifications when released to stock the 11 july 2013.Expiration date: 2016-05 (according to retained labels).No nc was opened.(b)(4) was opened relating to deals with the maintenance of the clean room, with no link with this complaint.(b)(4) was opened relating to deals with the calibration of the vac dry oven, with no link with this complaint.See detail in (b)(4).This report is being filed from the remetrex 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 rep reported three of his healix anchors broke during a rotator cuff procedure.The surgeon was inserting a 3.4mm healix br anchor with a tap when the distal tip broke.He removed all broken fragments and went to insert a healix transtend anchor into the same bone hole again with the tap and the distal tip also broke upon insertion.The surgeon removed the broken fragments and decides to insert a 3.4mm healix peek anchor.This anchor stripped out while inserting and could not be fully inserted.While the surgeon was attempting to unscrew this anchor, it broke into pieces.The surgeon removed a few fragments but ended up tapping the rest of the broken fragments into the bone.He then was able to successfully insert a healix advance anchor with no issues.There were no patient consequences.There was a 5 minute delay.This was a (b)(6) male patient with hard bone and this was the surgeons first time using healix transtend.All complaint devices were discarded.No further information was available.Please see also medwatch report 1221934-2018-53665 and 1221934-2018-53670.

• Brand Name: HEALIX PEEK 3.4 MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7690854
• Report Number: 1221934-2018-53664
• Device Sequence Number: 14146219
• Product Code: MAI
• UDI-Device Identifier: 10886705023837
• UDI-Public: 10886705023837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2013

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: 05/01/2016
• Device Catalogue Number: 222344
• Device Lot Number: 3711039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2013
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1