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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/18/2019
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 by the (b)(6) that a patient had a primary procedure on (b)(6) 2019 in which an ar-2653cr clavicle fracture plate central third (right) with inter screws was implanted.A revision right clavicle hardware removal procedure took place on (b)(6) 2019 and was performed by the same surgeon who performed the primary.The revision procedure operative report notes an arthrex ten hole clavicle plate (right) broke in the fifth screw slot from the lateral edge.Surgeon also noted that at the sixth screw hole there was bending of the plate not obviously appreciated on the x-ray.The following arthrex product was implanted during the primary (b)(6) 2019 procedure, and explanted during the (b)(6) 2019 revision procedure; ar-2653cr // lot: 6791239 // qty.: 1, ar-2665-14h // lot: 1003473 // qty.: 1, ar-8835-10 // lot: 031640 // qty.: 2, ar-8835-12 // lot: 10212120 // qty.: 1, ar-8835-14 // lot: 10325008 // qty.: 3, ar-8835-14 // lot: 10325012 // qty.: 1, ar-8835-14 // lot: 10325213 // qty.: 1, ar-8835-16 // lot: 10344449 // qty.: 1, ar-8840-10 // lot: 10010746 // qty.: 1.There was not an arthrex sales representative present during the revision procedure.The lead nurse reported to the rep that the patient claims they were lying in bed and felt a "pop." the rep reported that all explanted hardware is in their possession and will be returning to arthrex.Additional information obtained 1/13/2020: the oregon medical board reporter has provided the following additional information: the procedure on (b)(6) 2019 was to remove a ten-hole arthrex plate and install an eight-hole replacement device in the patient's right clavicle.It is unknown if the replacement device that was implanted was manufactured by arthrex.The replacement device installed on (b)(6) 2019 has since been removed on (b)(6) 2019 by a different surgeon, at a different facility, due to infection.The pre and post operative diagnosis was "infected right clavicle with hardware failure of plate fixation".The type of infection isn't clear but the records reference staphylococus that was resistant to penicillin.No plates or other devices were installed during the (b)(6) 2019 procedure.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke into two pieces near the middle oblong hole.Evaluation shows the plate was bent about 30 degrees before breaking.Likely causes include not following proper surgical technique, post-op noncompliance prior to full bone healing.Per surgical technique, bending the plate with excessive acute angles may potentially lead to plate fatigue, failure, and/or breakage in-situ.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9631368
• Report Number: 1220246-2020-01604
• Device Sequence Number: 16778036
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Device Lot Number: 6791239
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other