MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GRYPHON

Catalog Number UNK GRYPHON

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

Patient Problem Osteolysis (2377)

Event Date 02/24/2014

Event Type  Injury  

Manufacturer Narrative

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.This report is being filed after the subsequent review of the following literature article: results of arthroscopic bankart repair with hill-sachs remplissage for anterior shoulder instability authors: nicolas bonnevialle and et al international orthopaedics (sicot) (2017) 41:2573-2580 doi 10.1007/s00264-017-3491-5 nicolasbonnevialle@yahoo.Fr departement d'orthopedie traumatologie du chu de toulouse, hopital riquet, place baylac, 31052 toulouse, france.Depuy mitek has been informed that the catalog number and lot number are not available. .

Event Description

This report was derived from a journal article stating: osteolysis around the anchors used for the remplissage was identified in two cases on bernageau view, without clinical consequences.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.No valid mitek part or lot numbers were supplied which precludes conducting a device history record (dhr) review.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Depuy synthes has been informed that the catalog number and lot number are not available.

• Brand Name: UNKNOWN GRYPHON
• Type of Device: UNKNOWN GRYPHON
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7522235
• MDR Text Key: 108609691
• Report Number: 1221934-2018-50670
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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 GRYPHON
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR