MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE-BENDING PRESS; INSTRUMENT, BENDING OR CONTOURING

Model Number	329.30
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date, the plate bending press did not press.The issue was found during routine inspection.There is no patient involvement.This report is for one (1) plate-bending press.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: a review of the device history record.Device history lot.Part: 329.300.Lot: 7826102.Manufacturing site: hägendorf.Release to warehouse date: 04.May.2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary service and repair evaluation: the customer reported the plate bending press will not press.The repair technician reported the device was missing a spring and ball.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: small spring, lower anvil and ball.The item was repaired per the inspection sheet, passed synthes final inspection on 13-mar-2020 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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: PLATE-BENDING PRESS
• Common Device Name: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9812063
• Report Number: 2939274-2020-01191
• Device Sequence Number: 16304471
• Product Code: HXP
• UDI-Device Identifier: 10886982191953
• UDI-Public: (01)10886982191953
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 329.30
• Device Catalogue Number: 329.30
• Device Lot Number: 7826102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1