MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222242
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via email, that during an achilles repair, when inserting a 5.5 healix ti anchor w/ orthocord and needles, device had its head rolled, making it impossible to continue its screwing.The procedure was finished with a replacement.No surgical delay or patient consequence reported.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > according to the information provided, it was reported that during use, the anchor head rolled making it impossible to continue screwing.The complaint device was received and evaluated.Visual inspection revealed a damage in internal portion of the handle.The suture was not returned and the anchor head was received separated from the device which indicates that it broke.Further investigation under magnification disclosed that the end of the metal shaft was bent and at the upper part of the anchor there were indications of a breakage.No other anomalies were noted.Therefore the complaint was confirmed.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.This type of anchor breakage is consistent with historical investigations in which it was determined that the possible root cause was likely a combination of torque, bending axis insertion and bone hole.Other than this possibility, we cannot discern a root cause for this failure.A manufacturing record evaluation was performed for the finished device [4l69080] number, and no non-conformances were identified at this 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 to monitor the extent to which this complaint is observed in the field.Device history lot = > a manufacturing record evaluation was performed for the finished device [4l69080] number, and no non-conformances were identified.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9617856
• Report Number: 1221934-2020-00266
• Device Sequence Number: 2677025
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: 10886705007882
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2020

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: 04/30/2022
• Device Model Number: 222242
• Device Catalogue Number: 222242
• Device Lot Number: 4L69080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 03/27/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/20/2020; 03/30/2020
• Patient Sequence Number: 1