MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS TRAY CO 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Bent (1059); Component or Accessory Incompatibility (2897)

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

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).Locking ring, packaged with the humeral tray, was bent.

Event Description

During the procedure, the surgeon was not able to seat the bearing onto the humeral tray due to a bent locking ring.Another tray was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Dimensional evaluation found component to be within appropriate design specification and there was no evidence of product nonconformance.The complaint was confirmed as the locking ring showed evidence of being bent; however, it most likely occurred during attempts to assemble the component.

• Brand Name: COMP RVRS TRAY CO 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5833115
• MDR Text Key: 50738811
• Report Number: 0001825034-2016-02785
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 927370
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1