MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK; BONE PLATE

Model Number	04.503.831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Date of event: date of device breakage is not known.Returned to manufacturer.Subject device has been received and is currently in the evaluation process.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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with a titanium matrix-mandible subcondylar plate lambda left-1.0mm thick and six (6) titanium screws on (b)(6) 2017.X-ray taken on (b)(6) 2017 revealed the plate was broken.Patient was returned to surgery on (b)(6) 2017 for removal of the broken plate, reduction of the left condylar fragment into fossa, bone grafting of defect and fixation with reinforced titanium plates and screws under general anesthesia.Surgery was completed successfully.Patient reported to be recovered well and currently being followed-up at the consultation clinic.Concomitant devices reported: 2.0mm titanium screw 8mm (part number unknown, lot number unknown, quantity 3), 2.0mm titanium screw 10mm (part number unknown, lot number unknown, quantity 3).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a device history record review was performed: product manufacture date: 26-jan-2015.Product manufacture location: (b)(4), part number: 04.503.831.Lot number: 7902507.A review of the device history record (dhr) revealed no nonconformance.The (dhr) shows this lot of ti matrixmandible subcondylar plate lambda/left/1.0mm thick was processed through the normal manufacturing and inspection operations with no non-conformance or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance or rework noted.There are no nonconformance reports associated with this lot.This order met all dimensional, packaging and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A product development investigation was performed for the subject device: the returned device was received loose in a bag and is laser etched p/n 04.503.831 lot#7902507, and an ¿l¿.A visual inspection of the ti matrixmandible subcondylar plate (right) shows the plate is bent/twisted, has heavy gouges and damage on several holes and one hole is broken through both walls.Hole 1 has a heavy gouge on the bottom of the plate and countersink.Hole 2 is substantially damaged.The part is broken through the sidewalls of hole 2, such that the part is in two pieces.As a result of the damage few measurements can be made.The closest adjacent hole that does not have damage to the feature has been used to verify measurement conformance as all holes are made with the same tools and processes.Hole 3 is bent downward and has minor thread and minor countersink damage.Hole 4 is bent downward and has minor thread and minor countersink damage.Hole 5 is bent downward and has minor thread and minor countersink damage.Hole 6 is bent upward and has minor thread and minor countersink damage hole 7 is bent upward and has minor thread and minor countersink damage.The beam has heavy gouges and scratches and is deformed.The measurable dimensions were checked and found to be in compliance with the valid technical drawings.This lot met all dimensional and visual criteria at the time of release for shipment with no issues documented that would contribute to the complaint condition, it has been concluded any damage, breakage, gouges/scratches or out of specification condition due to damage occurred after the product left manufacturing.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: TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK
• Common Device Name: BONE PLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7060466
• Report Number: 3003506883-2017-50002
• Device Sequence Number: 11084593
• Product Code: JEY
• UDI-Device Identifier: 10887587023199
• UDI-Public: (01)10887587023199(10)7902507
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K091233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.503.831
• Device Catalogue Number: 04.503.831
• Device Lot Number: 7902507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/29/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention