MAUDE Adverse Event Report: ARTHREX, INC. VAL SCREW, TI, 1.6 X 10MM; PLATE, FIXATION, BONE

Model Number	VAL SCREW, TI, 1.6 X 10MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/17/2020
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 during a right hand orif of 4th and 5th metacarpal fractures procedure the surgeon was using the arthrex mini comprehensive fixation system ar-18700fs.When surgeon was reducing the 4th metacarpal fx the point-to-point clamp tips on the ar-18700-45 bent.Another issue occurred when he was plating the 5th metacarpal later in the case.He was using the depth gauge ar-18700-27 (from the ar-18700fs) to measure the length of the screw and the depth gauge pin assembly bent in multiple directions.There was another issue with two of the val 1.6mm screws that were placed in the plate located on the 5th metacarpal.When advancing a 1.6 x 09mm screw, ar-18716v-09, the screw head snap off the screw before the threads of the locking had ever engaged with the plate.This happened in the exact same way with a 1.6 x 10mm screw, ar-18716v-10.The screw threads that had made it through the plate and that were advanced into the bone were left in the patient's bone.Additional information obtained 11/30/2020: the ar-18700-45 and ar-18700-27 were from the ar-18700fs instrument set.The two instruments will be returned for evaluation.The proximal ends of the ar-18716v-09 and ar-18716v-10 were both disposed of at the time of procedure.To prep the bone socket for insertion of the screws the surgeon used and ar-18700-12 (1.2mm drill bit).The patient bone quality was reported to be good.This was a revision procedure so the bone was healing for 2 months when the patient fractured it again.The patient still had bone callus from the previous injury.Additional information obtained 12/1/2020: the patient's original procedure was performed at a different facility and the date of the original procedure is unknown.During the original procedure a 3.5 headless cannulated screw (ar-8730-xx / length unknown) was implanted.The original procedure was an intermedullary screw fixation of the 5th metacarpal neck fracture.During the revision the surgeon attempted to explant the original screw but was unable to extract it from the 5th metacarpal bone.The screw was left in and the plate was placed over the top of the intermedullary screw in the 5th metacarpal.Screws were placed around the intermedullary screw, fixating the plate to the bone.

• Brand Name: VAL SCREW, TI, 1.6 X 10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11046363
• Report Number: 1220246-2020-02413
• Device Sequence Number: 11061142
• Product Code: HRS
• UDI-Device Identifier: 00888867313675
• UDI-Public: 00888867313675
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: VAL SCREW, TI, 1.6 X 10MM
• Device Catalogue Number: AR-18716V-10
• Device Lot Number: 047411944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/21/2020
• 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