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 Problem Tissue Damage (2104)

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 healix anchor.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 is report 2 of 2 for the same event.This report is being filed after the review of the following journal article: s.Carbone, et al, 2018 ¿ arthroscopic single-row repair of massive potentially irreparable postero-superior cuff tear¿, musculoskeletal surgery 102 (suppl 1): 513-519, (italy).Complications stated in article: "no intra-operative complications occurred; at the final follow-up, five patients (15, 6%) were not satisfied of the results and asked for revision surgery.Of those five patients, three had a re-tear as shown by sonography; two showed an unsatisfactory range of motion wilh inability of daily.

• 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
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9139297
• MDR Text Key: 160712598
• Report Number: 1221934-2019-58695
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SUTURE PASSERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/01/2019
• 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