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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH 15.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
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).
 
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Brand Name15.0MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceACCESSORIES, 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 Key10620919
MDR Text Key209633487
Report Number8030965-2020-07665
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K111437
Number of Events Reported1
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 Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.026S
Device Lot Number26P3633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
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
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