MAUDE Adverse Event Report: ARTHREX, INC. CONTURLK FEM OSTEO PLT LFT S/M; BONE FIXATION PLATE

Model Number	CONTURLK FEM OSTEO PLT LFT S/M
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07/24/2024, it was reported by a sales representative via phone that an ar-13110l-01 osteotomy plate all screws backed out and the plate collapsed.This occurred after use in a case and the patient requires a revision.The revision surgery was scheduled for (b)(6) 2024 and was completed successfully using a competitor osteotomy plate.No further injury to patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation confirmed.One unpackaged ar-13110l-01 batch, 5262319, was received for investigation.The visual inspection revealed scratches on both the front and back of the device.Additionally, it was observed that the threads in the central hole were damaged, suggesting they may have been cross-threaded.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.According to dfu-0098 at revision 1.G.Precautions.1.Surgeons must apply their professional judgment when determining the appropriate plate size based on the specific indication, preferred surgical technique, and patient history.2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.Or contact your arthrex representative for an onsite demonstration.The arthrex website also provides detailed surgical technique information and demonstrations.

• Brand Name: CONTURLK FEM OSTEO PLT LFT S/M
• Common Device Name: 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: jared engle ; 8009337001
• MDR Report Key: 20014585
• Report Number: 1220246-2024-07216
• Device Sequence Number: 7164264
• Product Code: HRS
• UDI-Device Identifier: 00888867088276
• UDI-Public: 00888867088276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CONTURLK FEM OSTEO PLT LFT S/M
• Device Catalogue Number: AR-13110L-01
• Device Lot Number: 15135829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Unknown
• Patient Weight: 136 KG