MAUDE Adverse Event Report: ORTHOFIX SRL TL+ TELESCOPIC LINEAR DISTRACTOR 70MM

Model Number 50-11010

Device Problem Fracture (1260)

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

Event Date 04/11/2014

Event Type  Injury  

Event Description

The info provided by the local distributor indicates: hosp name - (b)(6); date of surgery - (b)(6) 2014; body part to which device was applied: tibia/ankle; surgery description - non union; pt's info - (b)(6) years female pt, approx (b)(6), approx 178cm, severe rheumatoid arthritis.Telescopic linear distractor broke during application: after frame was assembled and applied on pt with x-wire fixation in calcaneus and fore foot (distal) and two xcaliber osteotite screws diaphyseal, compression was needed for proper reduction of arthrodesis of ankle joint.Suddenly the black part came loose from aluminium part.

Manufacturer Narrative

The complaint report form indicates: the device failure caused adverse effects to pt (loss of distraction/correction achieved); the surgery was not completed with the device; a replacement device was immediately available to complete the surgery; no clinically relevant increase of the procedure time; no add'l surgery required; copies of the operative report are not available; copies of the pre-operative x-rays are available; info on pt current health condition: pt suffers from severe rheumatoid arthritis.Previous arthrodesis with retrograde intramedullary nail failed, so now nail had to be removed, bone debrided and external fixation applied with prp-gel in between in order to succeed the arthrodesis.On (b)(6) 2014, orthofix (b)(4) received the following add'l inf: a post-operative x-ray is not available, however, a clinical intra-operative picture of the frame is available.The malfunction of the linear distractor took place also intra-operatively and surgery was completed by exchanging the device immediately.No harm was done to surgeon and/or pt, but surgery time was a little bit elongated due to the exchange.Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 50-11010, lot 22900930 before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.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 (b)(4) will provide you with a f/u report.Orthofix (b)(4) continue monitoring the devices on the market.(b)(4).

• Brand Name: TL+ TELESCOPIC LINEAR DISTRACTOR 70MM
• Type of Device: TL+ TELESCOPIC LINEAR DISTRACTOR 70MM
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer Contact: roberto donadello, mgr dir, vp ; via delle nazioni 9; bussolengo,verona ; IT ; 9045671900
• MDR Report Key: 3827816
• MDR Text Key: 4498105
• Report Number: 9680825-2014-00012
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-11010
• Device Catalogue Number: 50-11010
• Device Lot Number: 22900930
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 90