MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 30MMCORT, STRL; BONE FIXATION PLATE

Model Number LO-PRO SCRW,TI,3.0MMX 30MMCORT, STRL

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2023

Event Type  Injury  

Event Description

On 5/15/2023, it was reported by an arthrex employee via email that an ar-8952ts-05s gerade low profile-t-platte, an ar-8933v-24s low profile va locking screw, an ar-8933v-26s low profile va locking screw, an ar-8933v-28s low profile va locking screw, an ar-8933v-30s low profile va locking screw, and an ar-8933-30s low pro cortical screw were removed during revision surgery.After the original surgery, a postoperative x-ray showed residual metal fragments.This procedure took place on (b)(6) 2023.No further information has been reported.Additional information requested.

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.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 30MMCORT, STRL
• Type of Device: BONE FIXATION PLATE
• 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: 17078803
• MDR Text Key: 316852899
• Report Number: 1220246-2023-06858
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867210592
• UDI-Public: 00888867210592
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 30MMCORT, STRL
• Device Catalogue Number: AR-8933-30S
• Device Lot Number: 10460648
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/07/2023
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other