MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 15.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC

Catalog Number 03.404.026S

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

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is jnj representative. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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

Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the patient underwent for a surgery on left proximal femur. During reaming, the ria drill heads and the area of the shaft center of the driver shaft was solved. The four clamping springs of the drill head have all broken off and remains in the patient. It was unknown if the surgery was completed successfully. The patient outcome was unknown. Concomitant device reported: drive shaft for ria (part# 03. 404. 035, lot# unknown, quantity 1). Synream drill wire (part# 351. 706s, lot# 7l10833, quantity 1). This complaint involves one device. This report is for (1) 15. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).

• Brand Name: 15.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10620919
• MDR Text Key: 209633487
• Report Number: 8030965-2020-07665
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.404.026S
• Device Lot Number: 26P3633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/02/2020 Patient Sequence Number: 1

Treatment

DRIVE SHAFT F/RIA 2 L520; REAMROD Ø2.5 L950 W/OLIVE