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

Catalog Number UNK MINI ANCHOR

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

Patient Problem Osteolysis (2377)

Event Date 01/01/2002

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.The report was created as a result of a journal article.Our experience with repair of the scapholunate ligament using the mitek bone anchor the information of the authors of the journal article are: authors: j.Pilny, j.Kubes, i.Cizmar, r.Visna; acta chirurgiae orthopaedicae et traumatologiae cechosl., 72.2005; orthopaedic department of the regional hospital, kyjevská 44, 532 03 pardubice.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number are not available.Associated medwatch number 1221934-2018-53999.

Event Description

This report is being filed after the subsequent review of the following literature article: our experience with repair of the scapholunate ligament using the mitek bone anchor a case of osteolysis was reported in the article.

• Brand Name: UNKNOWN MINI ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7704658
• MDR Text Key: 114508314
• Report Number: 1221934-2018-54013
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MINI ANCHOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1