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U.S. Department of Health and Human Services

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

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SYNTHES SELZACH PATIENT SPECIFIC GUIDE WITH PLANNING NEUROLOGICAL STEREOTAXIC INSTR Back to Search Results
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.
 
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Brand NamePATIENT SPECIFIC GUIDE WITH PLANNING
Type of DeviceNEUROLOGICAL 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 Key6150952
MDR Text Key61654274
Report Number3000270450-2016-10292
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSD900.111
Device Lot NumberME16-OLE-SAT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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