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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A dhr 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 an nr was opened relating to "during active aeration phase, parameter n°35 "dec minimum number of pulses" should be of a minimum of 3 pulses.In cycle 17-0578-3, the dec number of pulses was of 1 only" with no link with this complaint.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed two similar complaints for this lot of devices.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.Udi: (b)(4).Associated medwatch: 1221934-2018-50589.
Event or Problem Description
The affiliate reported via email that during an unknown procedure on an unknown date once the anchors fixed, the thread broke.Per additional information provided by the affiliate on 10-26-12017: the procedure was a shoulder arthroscopy.The issue was detected during use.There was a 10 minute delay in the procedure.The procedure was able to be completed.The suture broke when tightening the knot.The suture was not in contact with an instrument during breakage.A suture cutter was not used.Per additional information provided by the affiliate on 11-17-2017: the procedure was completed with the anchor.The anchor was not removed.The original bone hole was used to complete the case.

• 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: 7494866
• Report Number: 1221934-2018-50590
• Device Sequence Number: 16478731
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1