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

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is company representative. Device deemed reportable on march 23, 2020. Investigation summary: visual inspection: the plate cutter for 1. 3mm/1. 5mm and 2. 0mm plates (p/n: 03. 130. 271, lot number: t164174) was received at us cq. Upon visual inspection, the jaw edges were deformed, and the silicone plate holder inserts were missing. Device failure/defect identified? yes. Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage. Document/specification review: no design issues or discrepancies were identified. Complaint confirmed? yes. Investigation conclusion: this complaint is confirmed as the jaw edges are deformed and the silicone 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 history: part number: 03. 130. 271. Lot number: t164174. Manufacturing site: (b)(4). Release to warehouse date: 11-dec-2018. A review of the device history records was performed for the finished device lot number, and no non-conformances were identified. 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 during a routine incoming inspection of a loaner set on an unknown date, the plate cutter was observed damaged. There were no patient and surgical involvement. This is report 1 of 1 for (b)(4).

• Brand Name: PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9961837
• MDR Text Key: 187899715
• Report Number: 2939274-2020-01829
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.130.271
• Device Catalogue Number: 03.130.271
• Device Lot Number: T164174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown