MAUDE Adverse Event Report: ARTHROSURFACE, INC. GRS GLENOID RESURFACING SYSTEM; SHOULDER JOINT PROSTHESIS, GLENOID COMPONENT

Catalog Number G000-0100

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is still under investigation.Additional information was solicited.A supplemental report will be submitted upon completion of the plant investigation.

Event Description

On (b)(6) 2022 it was reported to arthrosurface that during a shoulder replacement procedure the flexible peg drill failed.The metal coil on the peg drill became bent and uncoiled.A replacement peg drill was used and there was no negative patient impact reported.Additional information was solicited.

Manufacturer Narrative

The complaint is still under investigation.Additional information was solicited.A supplemental report will be submitted upon completion of the plant investigation.Additional information: the device was not available for return.Additional information was not provided upon request.The batch record was investigated by the manufacturer.There were no non-conformances or deviations reported by the manufacturer.The case will be monitored and a supplemental report will be submitted upon receipt of new and relevant information.

Event Description

On 02dec2022 it was reported to arthrosurface that during a shoulder replacement procedure the flexible peg drill failed.The metal coil on the peg drill became bent and uncoiled.A replacement peg drill was used and there was no negative patient impact reported.Additional information was solicited.

• Brand Name: GRS GLENOID RESURFACING SYSTEM
• Type of Device: SHOULDER JOINT PROSTHESIS, GLENOID COMPONENT
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: 28 forge parkway; franklin, MA 02038
• MDR Report Key: 13215395
• MDR Text Key: 285809136
• Report Number: 3004154314-2022-00001
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G000-0100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1