MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI 3 ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).The lot number is unknown.
Event or Problem Description
This file is a review of the following journal article: yamakado, k, et al (2019) a prospective randomized trial comparing suture bridge and medially based single-row rotator cuff repair in medium-sized supraspinatus tears.Arthroscopy: the journal of arthroscopic and related surgery, vol.35, pages 2803-2813, (usa).The study emphasizes on the comparison of the clinical and imaging outcomes between the suture bridge technique (sb) and the medially based single-row technique (medsr) in patients with 1- to 3-cm tear sizes.The patients evaluated on course of this study: 166 patients.The article describes the following procedure: all patients were evaluated preoperatively and postoperatively (at 12 and 24 months) using the modified university of california, los angeles scoring system; active range of motion (flexion and external rotation); and a visual analog scale for pain.Healing status was examined by postoperative magnetic resonance imaging.The devices involved were: healix.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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: this complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Given that no lot number was provided, a manufacturing record evaluation (mre) or sterile load review cannot be performed.If the lot number becomes available, the mre review will be performed.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.

• Brand Name: 5.5 HEALIX TI 3 ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10778028
• Report Number: 1221934-2020-03292
• Device Sequence Number: 1088084
• Product Code: HWC
• UDI-Device Identifier: 10886705007899
• UDI-Public: 10886705007899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 222243
• Device Catalogue Number: 222243
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1