MAUDE Adverse Event Report: ORTHOFIX SRL TL PLUS HALF RING 180MM

Model Number 56-11650

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2014

Event Type  Injury  

Event Description

The info provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name: (b)(6); date of surgery: (b)(6) 2014; body part to which device was applied: used as arch over foot plate; surgery description: fracture treatment; pt's info: (b)(6) approx years female; problem observed into treatment.Event description: the corner of the half ring broke away (snapped) while pt was 6 weeks into her treatment.Pt had to have another half ring fitted (b)(6) 2014 as they were using this as the arch over the double and single row foot plates.The complaint report form indicates: no adverse effects to pt; the surgery was not completed with used device; no clinically relevant increase of the procedure time; an additional surgery was required; copies of the operative report are not available; copies of the x-rays are not available; info on pt current health condition is not available.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code (b)(4), lot 1207128 before the market release.No anomalies have been found.The original lot, manufactured in 2012, was comprised of (b)(4) devices.All of them have already been released to the market according to orthofix srl historical records, this is the first notification received from the device code (b)(4).Technical eval: the returned device received on (b)(4) 2014, is currently under technical eval.Medical eval: the info available on the case was sent to our medical evaluator.A preliminary medical eval was performed and will be finalized once the results of the technical eval will be available.As soon as further info and/or the results of the technical eval will be available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

• Brand Name: TL PLUS HALF RING 180MM
• Type of Device: TL PLUS HALF RING 180MM
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo, verona ; IT
• Manufacturer (Section G): OPERATIONS INTL, ORTHOFIX SRL
• Manufacturer Contact: roberto donadello, managing dir, ; via delle nazioni 9; bussolengo,verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 3842643
• MDR Text Key: 4681266
• Report Number: 9680825-2014-00013
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K941048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/15/2014

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: 56-11650
• Device Catalogue Number: 56-11650
• Device Lot Number: 1207128
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR