MAUDE Adverse Event Report: ACUMED LLC 20.0MM HEAD, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL

Model Number TR-H200L-S

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 12/20/2013

Event Type  Injury  

Event Description

During a radial head implantation surgery, a 7mm hole was broached with a 7mm broach; a 7mm trial stem fit correctly.When the 7mm sterile stem (with 20.0mm head, left) implant was implanted, it did not fit and would not stay in the broached hole.The surgeon then refit the broached hole with a 8mm sterile stem (with 22.0mm head, left) implant which fit satisfactorily.The mis-fit caused an extension in surgery time from a planned time of 3 hours to an actual time of 7 hours.

Manufacturer Narrative

Additional mdr associated with this event: 3025141-2014-00001, p/n tr-s0700-s, 7.0mm x 0.00mm stem.

• Brand Name: 20.0MM HEAD, LEFT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass rd.; hillsboro OR 97124 943
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass rd.; hillsboro OR 97124 943
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass rd.; hillsboro, OR 97124-9432 ; 5036279957
• MDR Report Key: 3842783
• MDR Text Key: 20109303
• Report Number: 3025141-2014-00002
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: TR-H200L-S
• Device Catalogue Number: TR-H200L-S
• Device Lot Number: 303515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention