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 product: unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: millar, n., et al.(2009) "open versus two forms of arthroscopic rotator cuff repair", vol.467, pages 966-978 (australia).This study emphasizes on comparing the clinical and structural outcomes of three different forms of rotator cuff repair with up to 24 months' follow-up.The patients evaluated on course of this study: three cohorts of patients had repair of a symptomatic rotator cuff tear using (1) an open technique (n = 49); (2) arthroscopic knotted (n ¿ 53); or (3) arthroscopic knotless (n ¿ 57) by one surgeon.Standardized patient- and examiner-determined outcomes were obtained preoperatively and at 6 weeks, 3 and 6 months, and 2 years postoperatively.Ultrasound studies were performed with a validated protocol at 6 months and 2 years post-surgery.The article describes the following procedure: arthroscopic rotator cuff repair.The devices involved were: metallic suture anchors (mitek rc quickanchor¿; depuy mitek inc, raynham, ma) (open group, n [6 months] ¿ 49, n [2 years] = 20), screw-in metallic suture anchor (mitek fastin®; depuy mitek inc) (arthroscopic knotted group, n [6 months] = 53, n [2 years] = 29), metallic knotless suture anchor (arthroscopic knotless group, n [6 months] = 57, n [2 years] = 38).Complications mentioned in the article were: all of these patients, except one in the knotted group in which an anchor pulled out 5 months post-surgery, required surgery as a result of traumatic events.

• 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: 9245253
• MDR Text Key: 178351444
• Report Number: 1221934-2019-59270
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2019

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
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 10/28/2019
• 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