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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE Back to Search Results
Model Number 03.404.020S
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 patient underwent a reamer irrigator aspirator (ria) - femoral bone graft harvesting.During the procedure, the reamer head broke off of the drive shaft when ria 2 was being removed from the femoral canal (distal third femur).Four (4) fragments were generated from reamer head and they were retrieved from the femoral canal with some difficulty using long punches/graspers.The procedure was successfully completed with a sixty (60) minute surgical delay.The patient's status is unknown.Concomitant device: unknown ria drive shaft (part#: unknown, lot#: unknown, quantity: 1).Unknown ria 2 (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) 12.0mm reamer head for ria 2 sterile.This is report 1 of 1 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.B6, h7, h9: 3008812560-10/26/2020-001-c.H3, h4, h6: part 03.404.020s, lot 34p3628: release to warehouse date: december 16, 2019.Expiration date: december 31, 2029.Supplier: jabil-monument.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection it was noticed that the proximal end of the reamer where it is inserted into the drive shaft has completely broken off and one of the broken pieces was not returned.No other issues were identified with the device.No dimensional inspection can be performed due to post-manufacturing damage.The complaint condition is confirmed.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.
 
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Brand Name
12.0MM REAMER HEAD FOR RIA 2 STERILE
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key10778797
MDR Text Key214369119
Report Number2939274-2020-04948
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886982273987
UDI-Public10886982273987
Combination Product (y/n)N
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/08/2020
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 Number03.404.020S
Device Catalogue Number03.404.020S
Device Lot Number34P3628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received11/03/2020
Supplement Dates Manufacturer Received11/11/2020
Supplement Dates FDA Received12/01/2020
Removal/Correction NumberSEE H10
Patient Sequence Number1
Treatment
UNK - RIA 2; UNK - RIA DRIVE SHAFT; UNK - RIA 2; UNK - RIA DRIVE SHAFT
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