MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE

Model Number 03.404.016S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Additional product code: hto. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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) 2021, during the first pass the reamer head for reamer irrigator aspirator (ria) 2 had broken inside the femur and four metal tabs popped off. The surgeon was able to retrieve the 4 tabs out of patient bone and got a new reamer head for ria 2. While working the bone distally, the reamer head broke again and the tabs fell out into the patient femoral canal. The surgeon was able to retrieve three of those tabs, and one remained in the patient¿s femur. Procedure was completed successfully with thirty(30) minutes delay. This report is for one (1) 10. 0mm reamer head for ria 2 sterile. This is report 2 of 2 for complaint (b)(4).

• Brand Name: 10.0MM 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
• 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: 12482960
• MDR Text Key: 271751095
• Report Number: 2939274-2021-05471
• Device Sequence Number: 1
• Product Code: HRX
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 58P1755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown
• Removal/Correction Number: Z-0571-2021

Patient Treatment Data

Date Received: 09/16/2021 Patient Sequence Number: 1

Treatment

10.0MM REAMER HEAD FOR RIA 2 STERILE