MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. BASEPLATE/GLENOSPHERE INSERTER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number INS-0990-861

Device Problem Break (1069)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during an rsa procedure, one (1) baseplate/glenosphere inserter broke inside a 10 deg full wedge baseplate.The screw thread broke off inside the baseplate.The procedure was resumed using a s+n back-up device.It is unknown if there was a surgical delay.

Event Description

It was reported that, during an rsa procedure, one (1) base plate/glenosphere inserter broke inside a 10 deg full wedge baseplate.The screw thread broke off inside the baseplate.No pieces fell inside the wound.The procedure was resumed using a s+n back-up device.

Manufacturer Narrative

H2: additional information ¿b5¿.

• Brand Name: BASEPLATE/GLENOSPHERE INSERTER
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18983890
• MDR Text Key: 338993578
• Report Number: 3002788818-2024-00044
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00885556812280
• UDI-Public: 885556812280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS-0990-861
• Device Lot Number: 22CNC0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1