MAUDE Adverse Event Report: ACUMED LLC 8.0MM X 2.0MM STEM; PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM

Model Number TR-S0802-S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2021

Event Type  malfunction  

Event Description

During a arh radial head replacement surgery, a stem implant box was opened.The labeling indicated it was an 8.00mm with 2.0mm collar but the implant inside was a 8.00mm stem wtih an 8.0mm collar.A new implant was obtained but this caused a 15-30 minute delay in surgery.

Manufacturer Narrative

Packaging and product labeled for tr-s0802-s was examined.The packaging was correct, and indicated sterile packaging of tr-s0802-s.The product inside the package does not have the dimensions detailed on the outer box packaging or the part print.(the stem is inserted in a head, making it impossible to see the direct part markings).Whereas the box and print state that the stem should be 8mm in diameter and the collar should be 2mm in height, the returned product had a 7mm stem and 8mm collar.This indicates that the packaged product was tr-s0708-s, rather than tr-s0802-s.The blister tray packaging label was reviewed in the device history record and it also indicates tr-s0802-s, batch 494005.

• Brand Name: 8.0MM X 2.0MM STEM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5032071387
• MDR Report Key: 12720476
• MDR Text Key: 280946746
• Report Number: 3025141-2021-00106
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TR-S0802-S
• Device Catalogue Number: TR-S0802-S
• Device Lot Number: 494005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• 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