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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The complaint device is not available for a physical evaluation.This complaint is not confirmed.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed without incident related to this complaint.Therefore, there is no evidence of manufacturing anomalies on the records reviewed which could result to the complaint reported.Further, a review into the depuy mitek complaints system revealed one other similar complaint for this lot of devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.(b)(4).
Event or Problem Description
The affiliate reported via email that during a shoulder arthroscopy, once the anchor fixed, the thread broke when tightening the knot.The anchor stayed inpatient and was fixed properly.Loss of 10 min.No patient consequences.The following additional information received via email from the affiliate on (b)(6) 2017 the procedure was able to be completed the procedure was completed with the anchor the anchor was already secured when the thread broke the surgeon did not have to use an additional anchor due to this failure the surgeon did not have to make an additional bone hole to complete this procedure it is unknown if alternatives were readily available.

• 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: 7364166
• Report Number: 1221934-2018-50339
• Device Sequence Number: 1052414
• 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): 10/26/2017

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
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1