MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES; INSTRUMENT, CUTTING, ORTHOPAEDIC

Model Number	03.130.271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part: 03.130.271, lot: t155241, manufacturing site: (b)(4), release to warehouse date: january 23, 2019.A review of the device history records was performed for the finished device lot number and no relevant nonconformance's were found.The final quality release criteria were met before this batch was released for distribution.Visual inspection: the plate cutter for 1.3mm/1.5mm and 2.0mm plates was received at us customer quality (cq).Upon visual inspection, one of the screws is loose since the stakes are broken.The silicone plate holder inserts are also missing.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as a screw is loose since the stakes are broken and the plate holder inserts are missing.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 during routine incoming inspection of a loaner set on an unknown date, it was observed that the plate cutter was damaged.There was no known patient or hospital involvement.Upon further investigation, it was determined that the device was broken.This report is for a plate cutter.This is report 1 of 1 for (b)(4).

• Brand Name: PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES
• 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: 9836651
• Report Number: 2939274-2020-01294
• Device Sequence Number: 3086630
• Product Code: HTZ
• UDI-Device Identifier: 10886982075475
• UDI-Public: (01)10886982075475
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.130.271
• Device Catalogue Number: 03.130.271
• Device Lot Number: T155241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1