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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 03.037.012
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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, the sales consultant was performing a demo for the surgeon when it was noticed that the drill bit was hitting the nail on the distal locking screw on a short tfna.There was no patient involvement.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# 1).This report is for 1 complete radiolucent insertion handle.This is report 1 of 4 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary visual inspection: the complete radiolucent insertion handle (p/n: 03.037.012, lot number: 9921276 ) was received at us cq.Visual inspection of the complaint device showed some scratches on the bottom of the handle that would not impact functionality or alignment.Functional test: a functional assessment was unable to be performed on the complaint device since all the mating devices were not returned.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no investigation conclusion: this complaint is not confirmed as a functional test could not be performed and there is no damage that would impact functionality/alignment.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: 03.037.012 lot: 9921276 manufacturing site: hägendorf release to warehouse date: 26 july 2016 a manufacturing record evaluation 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
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Brand Name
COMPLETE RADIOLUCENT INSERTION HANDLE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10225468
MDR Text Key197382133
Report Number2939274-2020-03070
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982070289
UDI-Public(01)10886982070289
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.037.012
Device Catalogue Number03.037.012
Device Lot Number9921276
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2020
Date Manufacturer Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
130 DEG AIMING ARM; UNK - DRILL BITS: TRAUMA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING; 130 DEG AIMING ARM; UNK - DRILL BITS: TRAUMA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
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