MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL; PLATE, FIXATION, BONE

Model Number CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that a revision clavicle surgery was performed on the (b)(6) 2021 due to a breakage of the device 11 weeks after the initial surgery.The initial surgery took place on the (b)(6) 2021.The breakage occurred with partial loading, without trauma and improper treatment.There was no evidence for an infection.The revision surgery was finished successfully and no broken parts remained inside the patient.

Manufacturer Narrative

Complaint confirmed, the plate was found to be broken at the 2nd oblong hole.The relevant and critical dimensions were found to meet specifications.Note that the plate was also bent at a different location, and no damage was observed on the screws that were returned.The cause of the event is undetermined.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12984740
• MDR Text Key: 283093103
• Report Number: 1220246-2021-04105
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867195929
• UDI-Public: 00888867195929
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL
• Device Catalogue Number: AR-2653CLS
• Device Lot Number: 5261911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other