MAUDE Adverse Event Report: SYNTHES OBERDORF TEMPL F/RESECTION DEFECT; TEMPLATE

Catalog Number SM121535

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).Patient weight is unknown.Event date: unknown.Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(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 and is pending completion.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was originally reported that there was an issue with a patient specific implant template.No patient or surgical involvement was indicated at the time.On (b)(6) 2015, however, updated information was received that indicated an issue with the cutting guide.The device did not have a smooth curvature, which resulted in difficulty resecting a patient¿s bone during a surgical procedure on an unknown date.The surgeon was unable to achieve the anticipated smooth ¿cure fashion.¿ the procedure was prolonged, but the exact length of time is unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: february 25, 2015.The declaration of conformity form the supplier was reviewed and no complaint related issues were found, according to the declaration was the device manufactured according to the specification.There are no further actions necessary as this complaint is not manufacturing related.A product development evaluation was completed: there was no device returned.The resection guide was designed according the existing bony skull surface represented in the patients ct dataset.The fit of a reprinted resection guide against a reprinted pre- and postoperative anatomical model of the patient¿s skull in the defect area was checked and can be confirmed.A resection guide gives the position and the direction of a cut, based on the resection, usually defined with the surgeon in a webex planning session, and the according designed psi.The planned, usually angulated cut that keeps the psi at its intended position by preventing it from falling toward the patient¿s brain, in combination with the anatomically shaped skull surface, that is, due to the already existing, old defect in this case quite recognizable, will lead to the not smooth curvature, the resection template seem to have, when you look at it in a 90 degree angle to the bony surface.If you look at the resection template in the direction of the planned cut, the same curvature on the skull surface is very smooth.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: TEMPL F/RESECTION DEFECT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5311233
• MDR Text Key: 33891962
• Report Number: 8030965-2015-12496
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033868
• 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: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SM121535
• Device Lot Number: 215006RT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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