MAUDE Adverse Event Report: SYNTHES SELZACH PATIENT SPECIFIC GUIDE WITH PLANNING; NEUROLOGICAL STEREOTAXIC INSTR

Catalog Number SD900.111

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient age/date of birth and weight are unknown event date: unknown; the device was discovered broken shortly before the procedure scheduled for (b)(6) 2016.(b)(4).Device is an instrument and is not implanted/explanted.It is unknown if the complainant part is expected to be returned for manufacturer review/investigation, but it 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 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 europe reports an event in (b)(6) as follows: it was reported that the surgical splint for orthognathic surgery arrived broken.It arrived shortly before the surgery scheduled for (b)(6) 2016.As a result, the surgeon had to make a new splint during the night before the operation.The models also had some minor damage; the new splint was not as precise as the original one that arrived broken.Therefore, the operating time was extended by approximately forty (40) minutes.It was reported that subsequently, the patient suffered damage (not further specified) as a result of the unnecessarily prolonged period of operation.No information available about patient condition and surgical outcome.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a device history record review was performed for: part # sd900.111 - me16olesat; manufacturing location; (b)(4); supplier: (b)(4); manufacturing date: 20.Sep.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.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

A manufacturing investigation was performed.The received information was forwarded to the responsible supplier for investigation: the complaint is related to a broken splint.For this complaint, the case history was investigated.It was noticed that on august 12, 2016 dental casts were received at materialise hq.Included in the box of the dental casts were splints that were manufactured by the hospital.Per request from the customer, only two genioplasty guides were designed and manufactured for this case.No splints needed to be designed and manufactured by materialise.On september 23, 2016, after the genioplasty guides were shipped to the customer, the sales representative of this case requested materialise by email to send all models and casts back to the customer by the next business day.Due to this urgent request, the casts and splints were shipped to the customer without additional protecting material.Accordingly, it is assumed that one of the splints broke during shipment.Moreover, it is highly unusual and not recommended for a customer to send splints to materialise that are still needed to be used intra-operatively without clear communication to the materialise team for its handling and/or return.Root cause process category: shipment (supplier) internal actions from supplier: rea was created to provide additional internal instructions on how to ship back casts and/or additional material to the customer upon request.The materialise clinical team manager will visit the hospital and will discuss the complaint investigation and events with the sales representative/surgeon.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 GUIDE WITH PLANNING
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTR
• 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: 6150952
• MDR Text Key: 61654274
• Report Number: 3000270450-2016-10292
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111558
• 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
• Report Date: 11/09/2016

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD900.111
• Device Lot Number: ME16-OLE-SAT
• 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: 09/20/2016
• 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
• Patient Outcome(s): Required Intervention