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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTER FOR TI ELASTIC NAILS INSTRUMENT, CUTTING, ORTHOPAEDIC Back to Search Results
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).
 
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Brand NameCUTTER FOR TI ELASTIC NAILS
Type of DeviceINSTRUMENT, 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 Key10310744
MDR Text Key199988689
Report Number2939274-2020-03275
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number359.217
Device Catalogue Number359.217
Device Lot Number5585688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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