MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Model Number 314.742

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

This patient information is unknown.Additional device product code: hrx.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an intramedullary canal lavage on (b)(6) 2018, when reaching the fracture point the reamer did not advance, the surgeon applied strength to the reamer but it did not advance.It was found out that the tip of the drive shaft was broken.The surgeon performed an x-ray scan of the entire leg of the patient, and a metal with a different density is evidenced, it is assumed to be the tip of the transmission tree.It was unknown if there was a surgical delay.The surgery was completed successfully.Patient status was unknown.Concomitant device reported: unk - reamer head (part number unknown, lot number unknown, quantity 1).This report is for one (1) drive shaft-minimum 360mm length-for use with ria.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7641183
• MDR Text Key: 112436441
• Report Number: 8030965-2018-54653
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189035
• UDI-Public: (01)10886982189035
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K042899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.742
• Device Catalogue Number: 314.742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention