MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIA 2 BONE HARVESTING KIT 520MM STERILE; REAMER

Model Number 03.404.000S

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional device product codes: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.Part number: 03.404.000s, synthes lot number: 76p1734, supplier lot number: n/a, release to warehouse date: october 20, 2020, expiration date: september 30, 2021, supplier: (b)(4).No ncrs were generated during production.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, an original ria 2 procedure was performed without incident.The surgeon chose to cut the tube of ria 2 tube as funnel for passing the bone graft into canal.There was an attempt to remove it, but the attempt failed.Fragments were generated.There was an unknown number of surgical delay.The procedure was successfully completed.Patient outcome was unknown.This report involves one (1).Ria 2 bone harvesting kit 520mm sterile.This is report 1 of 1 for (b)(4).

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11077060
• MDR Text Key: 223761641
• Report Number: 2939274-2020-05711
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 03.404.000S
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 76P1734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 156