MAUDE Adverse Event Report: FH INDUSTRIE ARROW; GLENOSPHERE COCR D42

Model Number	265152 - CoCr GLENOSPHERE, Ø42
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Des résidus blancs ont été observés sur plusieurs implants.Le chirurgien a dû en nettoyer un avant de l'implanter.White residues were present on several implants.The surgeon had to wash one in order to implant it.

• Brand Name: ARROW
• Common Device Name: GLENOSPHERE COCR D42
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 7322852
• Report Number: 3003898228-2017-00015
• Device Sequence Number: 152056
• Product Code: KWS
• UDI-Device Identifier: 03661489651526
• UDI-Public: (01)03661489651526(17)180329(10)D00039-AND-(01)003661489651526(17)180929(10)D01966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2018
• Device Model Number: 265152 - CoCr GLENOSPHERE, Ø42
• Device Catalogue Number: 265152
• Device Lot Number: D00039 AND D01966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1