MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMANDIBLE 7X23 ANGLE RECON PLATE LEFT 2.8MM THICK; BONE PLATE

Catalog Number 04.503.772

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, prior to the mandibula reconstruction surgery, that the mandibula plate was broken during bending.The surgeon used the correct instruments to apply the bending.No patient was involved because the mandibula plate breaking happened during the preparation outside the procedure.Another plate was used for the surgery.This report involves one (1) ti matrixmandible 7x23 angle recon plate left 2.8mm thick.This is report 1 of 1 for (b)(4).

Event Description

Updated event description: concomitant device reported: unk - bending inst: plate bender: tr (part#unknown, lot#unknown, quantity 1).This complaint involves one (1) device.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The breakage of the plate could be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot reviewed: apr 09, 2020.A dhr review was not performed for this pi.This lot was manufactured by elmira.Please assign this task to the correct group.Part number: 04.503.772, lot number: 13l2175, part manufacture date: jul 26, 2019, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti matrixmandible 7x23 angle recon plate left 2.8mm thick product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging 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 nonconformance noted.This raw material 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.Device history review this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 7X23 ANGLE RECON PLATE LEFT 2.8MM THICK
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9995282
• MDR Text Key: 189333392
• Report Number: 8030965-2020-03079
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819973985
• UDI-Public: (01)07611819973985
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2020

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: 04.503.772
• Device Lot Number: 13L2175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/14/2020
• Patient Sequence Number: 1
• Treatment: MATRIXMAND RECO-PL ANGL LE 7+23HO T2.8 T; UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA