MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); 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.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: tae, sk., et al (2002), bankart procedure through lateral capsulotomy in traumatic anterior instability of the shoulder, journal of korean orthopedic surgery, vol.37(5), pages 627-632 (korea, south).Doi: https://doi.Org/10.4055/jkoa.2002.37.5.627.The study emphasizes on evaluating the results of the bankart procedure performed through the external capsular incision according to objective and subjective methods to identify the merits and problems.The patients evaluated on course of this study: between october 1997 and august 2000, a total of 34 patients (34 male and 3 female patients) with a mean age of 25.5 years old (range 15-35 years old) who underwent bankart procedure through lateral capsulotomy due to a traumatic anterior instability were included in the study.After the operation, passive extension exercise started within 3 days and active exercise was started 4 weeks later.Muscle strengthening exercise using a rubber band was started 6 weeks later.Non-contact exercise and weight exercise started at 3 months, and there was no restriction on sports activities after 6 months.The article describes the following procedure: a bankart procedure through lateral capsulotomy for patients with traumatic anterior instability.The devices involved were: suture anchors (mitek gii anchor, mitek, usa), non-absorbable suture.Complications mentioned in the article: 3 cases of axillary nerve palsy; one of which was accompanied by myofascial palsy but recovered within 2 months.2 cases of anchor pull-outs.2 cases of axillary subdural hematoma, which was treated by skin incision.7 cases of mild pain as residual symptom when doing severe exercise.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-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: 9278793
• MDR Text Key: 165080812
• Report Number: 1221934-2019-59430
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• 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