MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE SHORT CUT PLATE CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number 03.503.057

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 (b)(6) reports an event as follows: it was reported that on an unknown date that the short cut plate cutters (03.503.057) were broken during a reconstruction surgery for a mandibular.The surgery was completed by using a trauma plate with a 30 minute surgical delay.Concomitant device: unknown plate (part # unknown, lot # unknown, quantity 1), this report is for one matrixmandible short cut plate cutter.This is report 1 of 2 for (b)(6).

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.H10 additional narrative: d10 h3, h4, h6: part: 03.503.057.Lot: 3106974.Manufacturing site: hägendorf.Release to warehouse date: (b)(6) 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection of the shortcut has shown that the complained instrument is broken in two halves.The returned shortcut has shown wear marks, scratches and strongly damages on the cutting area of the instrument.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.The measurements of the hardness after the hardening procedure were within the specification.Summary: the received condition agree with the complaint description and the complaint therefore is confirmed.This product was manufactured in june 2009 and is now more than 11 years old.The device was used many times.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance and we therefore assume that a mechanical overload situation led to the breakage.In this relation we would like to point out following part from important information: end of life of a device is normally determined by wear and damage due to use.We therefore recommend checking cutting tools after cleaning and damaged or blunt instruments to be replaced before surgery.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The root cause was identified during the performed customer quality (cq) evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: MATRIXMANDIBLE SHORT CUT PLATE CUTTER
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9738469
• MDR Text Key: 191300027
• Report Number: 8030965-2020-01289
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 07611819894426
• UDI-Public: (01)07611819894426
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.057
• Device Lot Number: 3106974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN; SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN; TIPREMED RECON PL/SM/RT/2.5MM THK-ST