MAUDE Adverse Event Report: SYNTHES SELZACH PLANNED OUTCOME MODEL MANDIBLE, CLEAR; TEMPLATE

Catalog Number SD900.231

Device Problem Material Distortion (2977)

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

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Device is used on single patient and a single surgery.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the bone model was not accurate when received by the hospital.The measurement of the bone model was 5mm off.After sterilization of the device, it deformed and hardened.The device could not be used for its intended purpose.The reported issue had no influence on the outcome of the patient, however the surgery was prolonged for 60 minutes.The sterilization of the model was performed according to the instruction.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

A device history record review was performed for the complaint part & device lot.(b)(4) - me16tuckeb.Manufacturing location: (b)(4).Manufacturing date: 20.Jul.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Synthes manufacturing location was discovered upon receipt of subject device.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing investigation was performed for the subject device (brand name plann mod mandib clear, part number sd900.231, lot number me16-tuc-keb).The subject device was returned with the complaint condition stating that model was already not 100% accurate when the hospital received it.It was about 5mm offset as it should be.But after sterilization the model was completely useless as the hardening spoiled very high.There was no patient involvement.For this complaint, the guide design (model) and production steps were investigated.The anatomical models were designed correctly and according to the work instructions.The part preparation performed by medical production followed correctly the guidelines in the work instructions.It was found that due to a new batch of resin loaded into the machine used by central production for manufacturing of sla parts for medical in may 2016, the machine parameters are also impacted due to a change in viscosity.The energy in the machine needs to be increased as it has an impact on the shrinkage of the parts.To do so, laser power measurements are needed prior to initiating the next build, which are then loaded onto the machine to have a compensation factor during the additive manufacturing.After the new resin was loaded in may 2016, a copy/paste of a laser power measurement file was stored on the desktop of the machine pc and erroneous values were read onto the machine causing the compensation to be incorrect.This human mistake caused that the parts were geometrically inconsistent and it is the root cause of this complaint.Based to the problem in production, additional actions have been launched by the supplier.The complaint condition was confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device returned to manufacturer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient outcome is normal.Patient was longer under the anesthesia due to the prolongation.No other patient harm reported.The surgery was successfully completed.The hospital had to use the model as fallback for pre-bending mini plates ¿ but the model was not useable ¿ so the accuracy for this case was not the same as the planed, everything had to be done intra operatively without any references.

• Brand Name: PLANNED OUTCOME MODEL MANDIBLE, CLEAR
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6151733
• MDR Text Key: 61735855
• Report Number: 2520274-2016-15599
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD900.231
• Device Lot Number: ME16-TUC-KEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1