MAUDE Adverse Event Report: SYNTHES SELZACH PATIENT SPECIFIC SPLINT ORTHOGNATHIC, INTERMEDIATE; TEMPLATE

Catalog Number SD900.105

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device history records review was completed for part# sd900.105, lot# me16ocosov.Manufacturing location: (b)(4), manufacturing date: nov 24, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent the surgery for a bimaxillary osteotomy (with genioplasty).Surgeon was using proplan splints, with maxilla movement first.The intermediate splint was placed and did not fit.This caused an approximate 15 minutes delay to the surgery while the cause of the custom splint not fitting was being determined.Surgeon was concerned the mandible movements are not accurate.The maxillary plate was perfect with cutting guides.There was no adverse event to the patient as a result of this incident.The surgeon was pleased with outcome after the final result due to custom maxillary plate.Splint was not used for this portion of the procedure.This report is for one (1) patient specific splint orthognathic intermediate.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation was performed.The received information was forwarded to the responsible supplier for investigation: pars not received for investigation.For this complaint, the device history record was investigated for the intermediate splint.No inaccuracies were found on the image quality, segmentation, planning and guide design steps.Some minor inaccuracies were found between the registration of the dental cast and the provided ct images of the patient.These could have been caused either by the age of the dental cast being older than the ct images provided (ct scan date is from (b)(6) 2016; date of the impression of the dental cast is unknown, however these were provided to materialise on (b)(6) 2016) and/or by any orthodontic treatment that may have been ongoing on the patient in between the scan date and the surgery time (surgery date on (b)(6) 2016).These discrepancies between the ct scans and the dental cast were noted during the pre-planning phase and were discussed during the planning session; in consequence the surgeon was made aware of potential interferences with the splint.Based on the available information, the impact of these differences in the performance of the intermediate splint cannot be confirmed nor excluded, and therefore no root cause could be found to explain the alleged issue by the complainant.Since no root cause could be found to explain the alleged issue by the complainant; no actions would be defined for this complaint.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.

• Brand Name: PATIENT SPECIFIC SPLINT ORTHOGNATHIC, INTERMEDIATE
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach 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: 6224821
• MDR Text Key: 63962405
• Report Number: 3000270450-2017-10001
• 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
• Report Date: 12/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SD900.105
• Device Lot Number: ME16OCOSOV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2016
• 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