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

Model Number	314.742
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7641183
• Report Number: 8030965-2018-54653
• Device Sequence Number: 19441732
• Product Code: HTO
• UDI-Device Identifier: 10886982189035
• UDI-Public: (01)10886982189035
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 314.742
• Device Catalogue Number: 314.742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention