MAUDE Adverse Event Report: FH INDUSTRIE ARROW SHOULDER; ARROW GLENOSPHERE

Catalog Number 265152

Device Problems Product Quality Problem (1506); Device Issue (2379); Manufacturing, Packaging or Shipping Problem (2975); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2016

Event Type  malfunction  

Event Description

Presence of a white powder on the inner edge of the implant (glenosphere).

Event Description

The initial glenosphere was opened and dr kalb noticed what he refered to as "white powder" on the inside edge of the implant.It was then put aside and not implanted.

• Brand Name: ARROW SHOULDER
• Type of Device: ARROW GLENOSPHERE
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer Contact: ruillier ; 3 rue de la fôret; heimsbrunn, france 68990
• MDR Report Key: 6581091
• MDR Text Key: 177369090
• Report Number: 3003898228-2017-00001
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 04/14/2018
• Device Catalogue Number: 265152
• Device Lot Number: D00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1