MAUDE Adverse Event Report: ACUMED, LLC 8 HOLE DORSOLATERAL MIDSHAFT RADIUS PLATE; PLATE, FIXATION, BONE

Model Number 70-0075

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported the 8 hole dorsolateral radius plate (part number 70-0075) failed post-operatively approximately 13 weeks after the primary surgery.It was also reported post-operative office visit x-rays show the plate to be intact.; however, subsequent office visit films showed the failure of the plate resulting in non-union.Follow up was conducted which determined the patient had reported being compliant with post-op instructions.A revision procedure was performed on (b)(6) 2022 to explant the fractured plate and explant the screws and replace with competitor product.The current status of the patient is unknown.Additionally, the batch/lot number(s) of the implanted screws, except for one screw, were unknown, and only the plate involved in this event was returned for evaluation.The event date (when plate fracture occurred) is unknown.The event date provided in this report is an estimate based on the information provided.This is 1 of 8 reports for this event and is related to report numbers 3025141-2022-00081, 3025141-2022-00082, 3025141-2022-00083, 3025141-2022-00084, 3025141-2022-00085, 3025141-2022-00086, and 3025141-2022-00087 which are for the screws involved in this event.

Manufacturer Narrative

Manufacturing and inspection records were reviewed, and no anomalies were found.The returned 8 hole dorsolateral midshaft radius plate was examined visually under magnification.The fracture occurred across one of the middle slots and was noted to be a fast fracture due to overload.From the x-rays provided, it appeared that this slot was over the fracture site (diagonal/transverse fracture).The x-rays showed that the failure occurred over the fracture site, resulting in a twist of the plate and bones along with it.The surgical technique recommends that the middle of the plate be positioned over the fracture site to optimize compression.Placing a slot over the fracture site decreases the stability of the plate construct as there is less material to support the fracture.No screws were returned for this incident.Based on the information provided and the investigation performed, no definitive conclusion on the cause of the incident can be made.

• Brand Name: 8 HOLE DORSOLATERAL MIDSHAFT RADIUS PLATE
• Type of Device: PLATE, FIXATION, BONE
• 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: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14115965
• MDR Text Key: 289494143
• Report Number: 3025141-2022-00080
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0075
• Device Catalogue Number: 70-0075
• Device Lot Number: 289148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male