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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the ar-2653cl plate broke post op.The original date of surgery was (b)(6) 2020; clavicle fracture and reverse total shoulder.Patient is male, (b)(6); there was no known event that caused the break.A second surgery was done to remove the broken plate and a synthes plate was implanted.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2653cl plate and 8 screws total were received for investigation.Of the 8 screws received, 6 were locking and two were non-locking.All 8 were various sizes.Of the locking screws, four were found (using 12" caliper dial id:007) to be approximately.7", and two were found to be approximately.9".Of the two non-locking screws, one was found to be approximately.6", and the other was found to be approximately.9".Material analysis showed each screw was made of 316 stainless steel.It was assessed that the ar-2653cl plate broke at approximately 1.6" down, with both pieces returned for analysis.Visual inspection noted the presence of thread damage to the holes of the plate, and surface scratches/cuts proximal to the holes.Material analysis concluded that the plate met all as-received specifications.As such, the most likely cause of the event remains undetermined, although it was recorded that the patient experienced a non-union post-op.This submission also contains additional information that has been added to the event description is section b5.
Event or Problem Description
It was reported that the ar-2653cl plate broke post op.The original date of surgery was (b)(6) 2020; clavicle fracture and reverse total shoulder.Patient is male, 61; there was no known event that caused the break.A second surgery was done to remove the broken plate and a synthes plate was implanted.Additional information obtained 1/8/2021: the actual date of the revision surgery was (b)(6) 2020.Additional information obtained (b)(6) 2021: fda medwatch letter (mw5098291), for report that had been submitted by the surgeon, was received.Report states: "patient had a clavicle orif for chronic longstanding non-union of clavicle.Within 6 weeks plate was noted to have bent and broke completely at 10 weeks.".

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11117171
• Report Number: 1220246-2021-02445
• Device Sequence Number: 3923271
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2653CL
• Device Lot Number: 5262004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other