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

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.

• 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 Key: 10778797
• MDR Text Key: 214369119
• Report Number: 2939274-2020-04948
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273987
• UDI-Public: 10886982273987
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• 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 Number: 03.404.020S
• Device Catalogue Number: 03.404.020S
• Device Lot Number: 34P3628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/01/2020
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Treatment: UNK - RIA 2; UNK - RIA DRIVE SHAFT; UNK - RIA 2; UNK - RIA DRIVE SHAFT