MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX BR ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222238
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device is implanted in the patient and will not be available for a physical evaluation.This complaint is not confirmed.It was reported that the suture broke during tightening of the knot.No information regarding the procedure or the device used has been provided to determine a root cause for this failure.Device history record review indicated that this batch was processed with no evidence of manufacturing anomalies on the records reviewed.A review into the depuy mitek complaints system revealed two similar complaints for this lot released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.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.
Event or Problem Description
It was reported by (b)(6) that during a shoulder arthroscopy, it was observed that the thread broke while tightening the knot once the anchor was fixed.According to the reporter, the anchor was already secured when the thread broke.It was reported that the anchor stayed inside the patient and was fixed properly.The surgeon did not have to use an additional anchor due to this failure; however, there was a delay of 10 min to complete the procedure.The surgeon did not have to make an additional bone hole to complete this procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 6.5 HEALIX BR ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7943037
• Report Number: 1221934-2018-54855
• Device Sequence Number: 14037807
• Product Code: MAI
• UDI-Device Identifier: 10886705007844
• UDI-Public: 10886705007844
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 05/31/2020
• Device Catalogue Number: 222238
• Device Lot Number: L431784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1