MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD LT 3H; PLATE, FIXATION, BONE

Model Number	VOLAR DISTAL RAD PLT TI STD LT 3H
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/21/2019
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 sales rep, that during a distal radius fracture repair, the surgeon implanted an ar-8919vsl-03, volar distal radius plate and 3 screws, as the surgeon was placing the last two locking screws ar-8724v-20, the screws went completely through the volar plate.The surgeon then removed all five screws and plate, causing a 30 minute delay in surgery.Additional anesthesia needed to be administered to the patient for the delay.The surgeon completed the case using a different ar-8724vsl-20, volar plate and five new ar-8724v-20, screws without further delays or complications.Additional information obtained 11/25/2019: the sales rep has reviewed the original event description and has provided an updated description with corrected part numbers: it was reported by the sales rep, that during a distal radius fracture repair, the surgeon implanted an ar-8916vsl-03 (lot 10307271), volar distal radius plate.The surgeon placed all five of the screws into the place but noticed that the two distal screws, ar-8724v-20, had passed all the way through the locking holes onto the patients radius bone.They had attempted to engage the screw with the driver and reverse them through the plate but were unable to get them to pass back through.At this point they needed to remove the entire plate and replace it with another ar-8916vsl-03 and redo the fixation.This process took an additional 30 minutes.The surgeon noted that the fixation was not adversely affected by this process and the anesthesiologist advised the sales rep that the patient had no ill effects from the additional time under anesthesia other than just a longer procedure.The first ar-8916vsl-03 lot 10307271 (qty 1) and the screws implanted with that plate, at-8724v-20 (qty 5) were all removed during the same procedure and replaced with new.
Additional Manufacturer Narrative
Complaint confirmed.Even though the returned screws did not fall through the plate, the threads from the b and c holes were found to be stripped.A most likely cause is over-torquing the screws or not following the surgical technique.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 3H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9443999
• Report Number: 1220246-2019-01472
• Device Sequence Number: 2973192
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: VOLAR DISTAL RAD PLT TI STD LT 3H
• Device Catalogue Number: AR-8916VSL-03
• Device Lot Number: 10307271
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other