MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS RSS GLENOID BASEPLATE IMPACTOR-S; ORTHOPEDIC SHOULDER

Catalog Number IMP-0961-064-S

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi#: (b)(4).A review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.While records indicate that the affected part will be returned for investigation, the part has not yet been received and photographs were not provided, so the failure could not be confirmed.Previous similar investigations identified excessive force when impacting, normal wear and tear, and off-axis loading as potential causes for breakage or damage of similar instruments.If the part is later returned to integra this investigation may be reopened and updated.

Event Description

A customer reported that the glenoid base impactor broke off during impaction while performing a reverse total shoulder arthroplasty.The broken parts was recovered/retrieved form the surgical site and the rest of the black tip was thrown away.The procedure was completed with a replacement product and a 5 minutes surgical delay was reported due to product problem.

Event Description

N/a.

Manufacturer Narrative

Additional information- d9, g1, g6, h2, h3, h4, h6, h10 the glenoid baseplate impactor was returned for evaluation: a review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.Failure analysis - visual examination of the part identified that a portion of the radel plastic tip of the impactor head was broken off and missing.The failure was confirmed.Root cause - failure analysis of the returned part confirmed the potential causes for the instrument breakage of excessive force when impacting, normal wear and tear, and off-axis loading as identified by previous similar investigations.

• Brand Name: RSS GLENOID BASEPLATE IMPACTOR-S
• Type of Device: ORTHOPEDIC SHOULDER
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 11337455
• MDR Text Key: 233579678
• Report Number: 1651501-2021-00002
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IMP-0961-064-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR