MAUDE Adverse Event Report: ORTHOFIX SRL RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYST S

Model Number 99-36501

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6); surgeon name: (b)(6).Date of initial surgery: (b)(6) 2015; body part to which device was applied: wrist; surgery description: fracture treatment; patient information: (b)(6), female; type of problem: device functional problem.Event description: in the operating room, once opened the sterile packaging, the medical staff tested the functionality of the locking cams.During this operation one of the clamps of the fixator blocked and could not be unlocked anymore.As if it was "jammed/locked".As the medical staff was aware of the case of the week before, where another sterile fixator, with the same code and lot, had a functional problem, they immediately decided to use a pennig fixator.The complaint report form indicates: the device failure had no adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copy of operative reports is not available; comments: no x-rays, further information on patient and on the surgery have been provided as the problem occurred did not depend on operating conditions and did not have any adverse effects on patient.(b)(4).

Manufacturer Narrative

Analysis of historical records.Orthofix srl checked the internal records related to the controls made on the device code 99-36501 lot v1391555 before the market release.No anomalies have been found.The original lot, manufactured in march 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.Technical evaluation: the device involved was received by orthofix srl quality engineering department on june 3, 2015.The technical evaluation of the device involved is currently ongoing.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently ongoing and will be finalized once further information and/or the results of the technical analysis are available.As soon as further information and/or the results of the technical analysis are available, orthofix srl will finalize the investigation and provide you with a follow up report.

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device cod e 99-36501 lot v1391555 before the market release.No anomalies have been found.The original lot, manufactured in march 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.No other similar notification was received by orthofix (b)(4) on this specific device lot.Technical evaluation: the returned device, code 99-36501, received on june 3, 2015, was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) design specifications.The visual check did not evidence any anomalies.The functional check confirmed the problem notified -one of the two clamps was locked.This condition could be attributable to an excessive tightening.The device was unlocked applying appropriate force in the opposite direction, with standard instrumentation and then subjected to a functional check again, which evidenced the conformity of the device to orthofix (b)(4) design specifications.The complaint report form indicates: the device failure had no adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copy of operative reports in nit available; copy of operative reports in not available; copy of x-rays images is not available; comments: no x-rays, further info on patient and on the surgery have been provided as the 2 problem occurred did not depend on operating conditions and did not have any adverse effects on patient.The information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluation: "in this case a radiolucent fixator was being tested for functionality prior to surgery.It was discovered that one of the cams apparently became locked and could not be unlocked during this testing.They therefore used a different fixator for the procedure, which was carried out as planned.The patient came to no harm, because a second fixator was available with no delay.In the technical analysis it is clearly shown that the fixator was originally conforming to specifications.One of the ball joints was locked very strongly but could be released, after which the fixator performed normally.The incident could be attributable to local factors by the hospital staff." manufacturer comments: based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix (b)(4) specifications, conformity to orthofix (b)(4) specifications, orthofix (b)(4) can conclude that the problem that occurred is not device related.The analysis of the historical data evidenced that no other similar notifications have been received on devices belonging to the same lot.Orthofix (b)(4) continues monitoring the devices on the market.

• Brand Name: RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYST S
• Type of Device: RADIOLUCENT WRIST FIXATOR KIT COMPL
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni 9; bussolengo,verona ; IT
• Manufacturer Contact: roberto donadello,managing dir ; via delle nazioni 9; bussolengo,verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 4865098
• MDR Text Key: 5809870
• Report Number: 9680825-2015-00020
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99-36501
• Device Catalogue Number: 99-36501
• Device Lot Number: V1391555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Age: 43 YR