MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CMRH STEM TRIAL SZ. 03; MODULAR RADIAL HEAD INSTRUMENTS

Catalog Number TRL-310-03

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

The dhr shows that no nonconformances were generated for the 101 units in the lot, and all inspection received accept results.The devices (implant and trial) have not been returned to ils-(b)(4); therefore, no failure analysis can be conducted.

Event Description

1 of 2 reports - other mfg report number: 1651501-2019-00019.It was reported that during surgery on (b)(6) 2019, the implant stem (id trl-310-03 - cmrh stem trial sz.03) did not sit to the same depth that the trial did.It seemed that the trial size and implant size did not align.There became a fissure in the bone by the stem being driven deeper.No other patient injury was reported, and the device remains implanted in the patient.

• Brand Name: CMRH STEM TRIAL SZ. 03
• Type of Device: MODULAR RADIAL HEAD INSTRUMENTS
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8628404
• MDR Text Key: 145684548
• Report Number: 1651501-2019-00018
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TRL-310-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1