MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE/ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 391.990

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted. Visual inspection: the plate/rod cutter (product code: 391. 990 & lot no: t160451) was received at us cq. The visual inspection of the received device indicated that the cutting edges were dull and slightly deformed on both jaws. No other damages were observed on the device. Functional test: the functional test performed on the complaint device indicated that the jaws and handles of the device were not completely open when handles decompressed or released. This functional failure was consistent with the reported condition, thus the complaint was confirmed. The complaint can be replicated with the returned device(s) dimensional inspection: the dimensional inspection was not performed as it is irrelevant to the reported functional failure and also due to post-manufacturing damage of the jaws cutting edges. Document/specification review: the relevant drawing reflecting current and manufactured revision was reviewed: investigation conclusion: the overall complaint was confirmed for the received device as the device was not functioning as intended. While no definitive root cause could be determined based on the provided information, it is possible that the low spring temper or poor lubrication caused this functional failure of the device. The deformed cutting edges failure may be caused due to the excessive force. 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. Part number: 391. 990, lot number: t160451, manufacturing site: (b)(4), release to warehouse date: 15-aug-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

Veterinary complaint: it was reported that on an unknown date during an unknown case it was discovered that the plate rod cutter are not springing back open after use. These cutters primarily used with tibial plateau leveling osteotomy (tplo) and to cut the threaded pin for standard jig. No further information provided. During manufacturer's investigation of the returned device it was identified that the cutting edges were dull and slightly deformed on both jaws. This device condition was reassessed and determined as reportable on (b)(6) 2020. Concomitant devices reported: kirschner wire (part # vw3005. 15, lot # unknown, quantity unknown). This report is for 1 plate/rod cutter. This is report 1 of 1 for (b)(4).

• Brand Name: PLATE/ROD CUTTER
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• 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: 10329360
• MDR Text Key: 200619501
• Report Number: 2939274-2020-03305
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 391.990
• Device Catalogue Number: 391.990
• Device Lot Number: T160451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown