MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM; BONE PLATE

Catalog Number SD449.511B

Device Problems Material Deformation (2976); Material Distortion (2977)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: sd449.511b/h226726 mfg.Date: 14-nov-2016.No ncrs were generated during production.Dhr review found no relevant issues that would result in this product complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an initial unknown surgery, a patient specific implant was not an exact fit.The custom plate was not used and the surgeon ended up using a standard plate that he had to bend intraoperatively.There was an approximate 20 minute delay in surgery with no harm to the patient.The surgery was completed successfully.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The implant was forwarded to product development (pd) for investigation where the complaint condition was unable to be confirmed.The patient specific plate contouring (pspc) implant investigation as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for pspc contouring.The investigation revealed that the pspc was contoured according to the resection boundaries specified by the requestors and the plate mated the contour of the 3d printed model.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A pd investigation and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.The device was returned the depuy synthes r&d for evaluation.The plate arrived in multiple pieces, as described in the complaint description, and it was noted to have been cut in 2 places during surgery; all pieces were returned.The plate is in otherwise good condition and shows no sign of wear or damage.The following factors were considered during the investigation to determine if any may have contributed or caused the event described in the complaint: device design, material of construction, packaging, tolerance stack-up/mating parts/compatibility, sterilization, labeling, user technique and manufacturing specification.In each instance no evidence was identified indicating that the factor could have caused or contributed to the complaint condition.In conclusion, the pspc implant investigation as part of this complaint passed all design and manufacturing quality checks as proscribed by the relevant work instruction for pspc contouring.The investigation revealed that the pspc was contoured according to the resection boundaries specified by the requestors and the plate mated the contour of the 3d printed model.The investigation will be dispositioned as unconfirmed.No root cause was determined during the pd investigation.The device was not implanted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6228875
• MDR Text Key: 64057591
• Report Number: 2530088-2017-10001
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD449.511B
• Device Lot Number: H226726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 90