MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - SUTURE PASSERS; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number UNK - SUTURE PASSERS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 04/04/2012

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.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 report is being filed after the review of the following journal article: boileau, p., et al (2012), anatomical and functional results after arthroscopic hill-sachs remplissage, the journal of bone and joint surgery, vol.94-a no.7, pages 618-626 (france).Doi: 10.2106/jbjs.K.00101.The study emphasizes on determining the safety and efficacy of the novel arthroscopic combined procedure in a cohort of patients with a large and engaging posterosuperior humeral defect but no substantial glenoid deficiency.The patients evaluated on course of this study: between september 2005 and april 2009, 47 patients (42 male and 5 female) who underwent surgery for the treatment of traumatic, recurrent anterior glenohumeral instability were included in the study.The average age at the time of surgery was 29 ± 5.4 years (range, range, 14 to 58 years).Postoperatively, the arm was placed in a sling in neutral rotation for four weeks.Self-directed rehabilitation with pendulum exercises was started on the day after surgery (5 times a day, 5 minutes each session).Formal physiotherapist-supervised rehabilitation commenced at 4 weeks following surgery.The patients were permitted to return to sports activity between 3 and 6 months postoperatively.Ct arthrograms of the operatively treated shoulder were obtained at least 6 months after surgery.The article describes the following procedure: arthroscopic hill-sachs remplissage in combination with a bankart repair.The devices involved were: spiralok suture anchors (depuy mitek, raynham, massachusetts), lupine suture anchors (depuy mitek, raynham, massachusetts), cleverhook, penetrating grasper (depuy mitek), shaver, 2 single-loaded anchors.Complications mentioned in the article: 1 patient had a traumatic glenohumeral re-dislocation at 25 months postoperatively, sustained during a fall while playing basketball landing on the abducted upper extremity.1 patient reported some discomfort when the arm was maximally externally rotated in 90° abduction.6 patient returned to a lower level of sports activity.1 patient underwent a repeat surgery for symptomatic persistent tenosynovitis of the long head of the biceps tendon.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , 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.Upon complaint review, it was determined that the date of event was inadvertently missed on the initial report; therefore, the date of event has been updated accordingly to reflect the correct information.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.

• Brand Name: UNK - SUTURE PASSERS
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9167078
• MDR Text Key: 172928991
• Report Number: 1221934-2019-58842
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SUTURE PASSERS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention