MAUDE Adverse Event Report: SYNTHES ELMIRA TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK; BONE PLATE

Catalog Number 04.503.740

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that the matrix mandible plate was broken when the dental technician tried to conduct pre-bending before surgery.Due to the breakage, the dental technician used an alternate plate instead to prepare for the mandible segmentectomy surgery and successfully contoured the alternate plate.The surgeon used the alternate plate in surgery and the surgery was completed without any problems.There was no surgical delay.There was patient involvement as the reported event happened during pre-surgical preparation.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device broke prior to the surgical procedure and was not implanted or explanted.Product investigation summary: visually, there were several cut off pieces on the returned plate.Some of those pieces were not cut off, they were broken off.Traces of use with the bending pliers and scratches on surface were detectable.The breakage happened during pre-bending.It is likely that an overloading situation occurred that led to the breakage.Please note: it is recommended that the user avoid reverse bends as they may weaken the plate and lead to premature implant failure.The exact root cause could not be defined, but no manufacturing related failure was found.Device history record review: manufacturing location: october 10, 2014.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 7819809 was processed through the normal manufacturing and inspection operations with no scrap or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 7376312 met all specifications.A review of the raw material device history record(s) determined the billet material lot 7686130 met all specifications.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

Correction: there was no patient involvement as the reported event happened during pre-surgical preparation.

• Brand Name: TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5268428
• MDR Text Key: 32721905
• Report Number: 2520274-2015-17688
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063790
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.740
• Device Lot Number: 7819809
• Other Device ID Number: (01)10887587022888(10)7819809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1