MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANTS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANTS

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown implant device.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

This is report 1 of 2 for the same event.This report is being filed after the review of the following journal article: mccarron, j., et al.(2013) "failure with continuity in rotator cuff repair ''healing", the american journal of sports medicine, vol.41, no.1, pages 134-141 (usa).This study emphasizes on measuring the prevalence, timing, and magnitude of tendon retraction after rotator cuff repair and correlate these outcomes with formation of a full-thickness recurrent tendon defect on magnetic resonance imaging, as well as clinical outcomes.The patients evaluated on course of this study: fourteen patients underwent arthroscopic rotator cuff repair.Tantalum markers placed within the repaired tendons were used to assess tendon retraction by computed tomography scan at 6,12, 26, and 52 weeks after operation.Magnetic resonance imaging was performed to assess for recurrent tendon defects.Shoulder function was evaluated using the penn score, visual analog scale (vas) score for pain, and isometric scapular-plane abduction strength.All rotator cuff repairs retracted away from their position of initial fixation during the first year after surgery (mean [standard deviation], 16.1 [5.3] mm; range, 5.7-23.2 mm), yet only 30% of patients formed a recurrent defect.Patients who formed a recurrent defect tended to have more tendon retraction during the first 6 weeks after surgery (9.7 [6.0] mm) than those who did not form a defect (4.1 [2.2] mm) (p =.08), but the total magnitude of tendon retraction was not significantly different between patient groups at 52 weeks.There was no significant correlation between the magnitude of tendon retraction and the penn score (r = 0.01, p =.97) or normalized scapular abduction strength (r = -0.21, p =.58).However, patients who formed a recurrent defect tended to have lower penn scores at 52 weeks (p =.1).The article describes the following procedure: rotator cuff repair.The devices involved were: then, 5.0-mm fastin anchors, each loaded with a double strand of no, 2 orthocord suture (depuy mitek, warsaw, indiana), were inserted at the medial edge of the repair footprint.Complications mentioned in the article were: one bead in 1 patient came out of the tendon and migrated to the axillary pouch between 12 and 26 weeks and was subsequently removed arthroscopically.Four of 13 patients were considered to have a recurrent tendon defect at 52 weeks by mri assessment.The formation of a full-thickness, fluid-fluid gap in the tendon was first identified at 6 weeks in 1 patient, 12 weeks in another, and 26 weeks in 2 patients.

• Brand Name: UNK - IMPLANTS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9232841
• MDR Text Key: 177285666
• Report Number: 1221934-2019-59175
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention