MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTER FOR TI ELASTIC NAILS; INSTRUMENT, CUTTING, ORTHOPAEDIC

Model Number 359.217

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Visual inspection: the cutter for ti elastic nails was received at us customer quality (cq).Upon visual inspection, the tip of the cutting component is damaged/deformed.Service and repair evaluation: it was reported that on june 02, 2020, a cutter blade was rounded and dull.The repair technician reported the cutting edge is damaged.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Service and repair history: the previous service event for part 359.217 with lot 5585688 has been reviewed.The customer called in a service request for this item on (b)(6) 2020 for cutter blade was rounded and dull.The item was previously returned for service on (b)(6) 2013 due to damaged part, cracked housing.The previous service condition of damaged part, cracked housing is not relevant to the current complained issue of cutter blade was rounded and dull.The manufacture date of this item is august 24, 2007.The service history review is unconfirmed.Functional test: a functional assessment was performed on the complaint device.When the handle with ratchet tip is connected to the hex head of the cutting component, the ratchet does not ratchet when turned clockwise.A mating device was not returned to test whether the device can cut.The complaint condition can be replicated.Dimensional inspection: a dimensional inspection was not 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 the tip of the cutting component is deformed and the handle with ratchet tip does not ratchet when turned clockwise.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 Description

It was reported that on (b)(6) 2020, a cutter blade was rounded and dull.The issue was discovered during cleaning.There was no patient involvement.This report is for a cutter for titanium (ti) elastic nails.This is report 1 of 1 for (b)(4).

• Brand Name: CUTTER FOR TI ELASTIC NAILS
• 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10310744
• MDR Text Key: 199988689
• Report Number: 2939274-2020-03275
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10886982197153
• UDI-Public: (01)10886982197153
• 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: 06/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 359.217
• Device Catalogue Number: 359.217
• Device Lot Number: 5585688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1