MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SMALL PLATE CUTTER; INSTR,BENDING OR CONTOURING

Model Number 03.503.079

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.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.Device history record review has been requested.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

It was reported that when cleaning the matrixmandible plate cutters at the sterile processing department on (b)(6) 2018, the tension band broke off of the cutter.There was no procedure nor patient involvement.This report is for a matrixmandible small plate cutter.This is report 1 of 1 for (b)(4).

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.Supplier lot number: a7qa13.Possible synthes lot numbers: 5490917, 5524192 or 5543851.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.

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: h3, h4, h6: part: 03.503.079; synthes lot: a7qa13 (wo (b)(4)); release to warehouse date: n/a; manufacture site: n/a; part expiration date: n/a; list of non-conformances: n/a.The lot a7qa13 consists of 2 different tuttlingen production lots (wo).Manufacturing date and works order # are as follows: wo #: (b)(4), man.Date: 30.03.2007, quantity: (b)(4).Wo #: 914753, man.Date: 15.05.2007, quantity: (b)(4).A review of the 4 device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The hardness protocols are within specification.Traceability to the raw material lot number could not be established during this device history record (dhr) review, due to the age of the instrument.No nonconformance reports (ncrs) were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Investigation flows: broken & visual (appearance not as expected) visual inspection: visual inspection of the returned device performed at customer quality (cq) identified a missing "spring with slot" component and a broken m2.6x4 screw component.The head of the screw has sheared off and was not returned.A portion of the threaded screw shaft still remains secured in the handle.The screw that secured the "spring with slot" component to the handle component broke which resulted in the "spring with slot" component separating from the handle.The entire device shows cumulative wear commensurate with several years of use.This complaint is confirmed for the condition of breakage and missing component.Document/specification review: the returned device was manufactured in 2007 and is approximately eleven (11) years old.A review of the four (4) device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The hardness protocols are within specification.Traceability to the raw material lot number could not be established during this dhr review, due to the age of the instrument.No ncrs were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.The following design drawings were reviewed during this investigation: matrix mandible small plate cutter assembly design drawing.M2.6x4 screw component design drawing.The 03.503.079 matrixmandible small plate cutter is a reusable instrument used to cut matrix mandible plates 1.0mm through 1.5mm thick, to the desired length between the plate holes.No product design issues or discrepancies were observed.Dimensional inspection: the major thread diameter of the broken screw measured ø2.54mm at cq which is within specification of ø2.480 - ø2.580 per m2.6x4 screw component design drawing.The "spring with slot" component is missing (was not returned) and therefore a relevant dimensional inspection was not able to be performed.Material analysis: the design specified the screw to be manufactured from 304 stainless steel and passivated.A review of the four (4) device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The hardness protocols are within specification.Traceability to the raw material lot number could not be established during this dhr review, due to the age of the instrument.No ncrs were generated during the production of this device.Conclusion: a definitive root cause for the screw component breaking on the returned eleven (11) year old plate cutter could not be determined based on the provided information.The most likely cause is encountering excessive leverage force on the spring with slot component resulting in the screw head breaking off.This complaint is confirmed, however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11 corrected data: d4 ¿ lot, d10 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 SMALL PLATE CUTTER
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7797042
• MDR Text Key: 118106746
• Report Number: 2939274-2018-53376
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 10887587011929
• UDI-Public: (01)10887587011929
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.503.079
• Device Catalogue Number: 03.503.079
• Device Lot Number: A7QA13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1