MAUDE Adverse Event Report: ORTHOFIX SRL M2 MULTIPLANAR MINIRAIL

Model Number M511

Device Problem Device Maintenance Issue (1379)

Patient Problem No Code Available (3191)

Event Date 02/21/2014

Event Type  Injury  

Event Description

The info provided by the local distributor indicates: hospital name: (b)(6); date of surgery: (b)(6) 2014; body part to which device was applied: foot; surgery description: correction; pt info: plus or minus (b)(6) years male pt, (b)(6).Event description: after placing the m2 external fixator it could not be locked.This was because the radio-ulnar gives locking screw problems.No grib so no locking takes place.The second surgery was a further correction on one foot.During this operation, they have positioned a new m2 external fixator.The complaint report form indicates: the device failure caused adverse effects to pt (loss of distraction/correction achieved).The surgery was completed with the user device (a replacement device was not immediately available).The event led to a clinically relevant delay (there was a second surgery.The new m2 external fixator was positioned and at the same time there was a further correction on the foot).An additional surgery was not required.Copies of the operative reports and copies of the x-rays are not available.Note and comments: surgery could be completed, however, functionality of the external fixator was not optimal.On (b)(6) 2014, orthofix srl received the following additional info: the first surgery was performed on (b)(6) 201.The device code m511 did not function properly but as a replacement device was not immediately available, the device was left on pt.The delay occurred during the first surgery was 15-20 minutes.The pt was subjected to a second surgery.This surgery was already planned and during this second surgery the device was replaced.Pt diagnosis: corrective osteotomy, metatarsal.Details of the correction procedure (initial deformity, planned correction, correction achieved before device malfunction): planned correction.Due to infection of epiphysis at earlier age bones were not grown as they should.Date of second surgery: (b)(6) 2014.Copy of the x-rays and the operative reports: not available.Info about pt current health condition: not available.The device was at its first use.On (b)(6) 2014, orthofix srl received the following additional info: (b)(6) 2014: m2 multiplanar minirail applied to pt.(b)(6) 2014: planned second operation; metatarsal osteotomy performed.If the osteotomy was planned for this second operation, what correction was anticipated after the first operation? first operation was an osteotomy, second operation was the correction.It was initially intended to do 2 operations.This was not a result of the failing m511 device.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code m511 lot b123 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of 23 devices.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation: the returned device, received on 03/31/2014 was examined by orthofix srl quality engineering department.The device was subjected to visual, dimensional and functional check.The visual check evidenced that the seat of one of the locking screws is damaged.Therefore the movement of the corresponding gear cannot be stopped.The dimensional check did not evidence any anomalies.The functional check evidenced that the locking of the gear where the screw seat is damaged is not functioning.The device performs properly for all other extents.Orthofix failure analysis concluded that the device was originally conforming to design specifications.The damage detected may be attributable to incorrect use of the locking screw.The medical evaluation summary and the manufacturer comments are provided in the attached file (please kindly refer to "medical evaluation summary and manufacturer comments attached to mfr reports # 9680825-2014-00010").See scanned pages.

• Brand Name: M2 MULTIPLANAR MINIRAIL
• Type of Device: M2 MULTIPLANAR MINIRAIL
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer (Section G): ORTHOFIX SRL
• Manufacturer Contact: roberto donadello, manag. dir. vp ; via delle nazioni 9; bussolengo,verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 3779192
• MDR Text Key: 19920722
• Report Number: 9680825-2014-00010
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K955848
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M511
• Device Catalogue Number: M511
• Device Lot Number: B123
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• 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: 12 YR
• Patient Weight: 50