MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number	03.503.057
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: no patient involvement was reported.Date of device breakage is not known device is an instrument and is not implanted/explanted.Date returned to manufacturer.(b)(6).Subject device has been received and is currently in the evaluation process.(b)(4).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
It was reported that while the sales consultant was review his field equipment sets he noted that the matrix mandible plate cutter is broken in two pieces.Issue was discovered while putting sets together.There was no patient involvement.This report is for one (1) matrixmandible short cut plate cutter.(b)(4).
Additional 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.Additional narrative: a device history record (dhr) review was performed for part no.: 03.503.057, lot no.: 1896314, manufacturing location: (b)(4), release to warehouse date: 12.Sep.2008: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was performed.The returned cutter (03.503.057, 1896314) is a tool used in the matrixmandible, rib, and combo systems to cut plates.The returned cutter was received broken, with one half of the cutter head portion missing, which confirmed the complaint condition and made further replication inapplicable.The returned cutter (03.503.057, 1896314) was manufactured on 12sep08 and drawings 03_503_057 (rev e to rev j) and 03_503_057_2 (rev c to rev e) were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Dimensional changes to the cutting feature were made to improve the strength of the cutter head under dco 10017869 and capa 50488 (transferred to etq under capa 005491) with an updated drawing released for the cutter head in april 2010.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material properties of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material testing is not required.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Dimensional analysis performed at customer quality, measured thickness at the broken cross section to be 9.56 mm (calipers ca215p) which falls within specification of 9.4 mm to 9.6 mm based on 03_503_057_2 (rev c).Based on the available information it is not possible to determine a definitive root cause, but since the device was manufactured prior to the design change the device design likely contributed to the complaint condition.The current design was determined to be suitable for the intended use when employed and maintained as recommended.Therefore, from a design perspective this complaint is valid but is already being addressed under capa 50488/capa 005491 and dco 10017869 (a-688999).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
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7331655
• Report Number: 2939274-2018-51005
• Device Sequence Number: 109570
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783(10)1896314
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.057
• Device Lot Number: 1896314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1