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 Type  Injury  

Event Description

It was reported that on (b)(6) 2020, patient underwent a procedure the ria reamer malfunction with intramedullary nail breakage causing a couple of retained metal fragments. Device broke when the tip was attached between the reamer head and the shaft. It would have caused more problems to try to remove the fragments since what was placed was a large titanium tibial nail. Concomitant devices reported: unk - screws: trauma(part# unknown, lot# unknown, qty unknown); unk - nails: tibial(part# unknown, lot# unknown, qty 1). This report is for one (1) 10. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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.

• 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: 12923729
• MDR Text Key: 281662705
• Report Number: 2939274-2021-06940
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/03/2021 Patient Sequence Number: 1

Treatment

UNK - NAILS: TIBIAL; UNK - SCREWS: TRAUMA