MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.This report is for one (1) unknown tfna helical blade.Part#, lot# and udi # is not available.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided.This report is for one (1) unknown tfna helical blade.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that the patient underwent surgery for the femoral trochanteric fracture on (b)(6) 2017.The tfna was used for the procedure.Although the surgeon inserted the nail and the blade, it turned out at the end that the blade could not be installed in a right position.The procedure was ended as the tip of the blade was slightly protruded from the outer cortical bone.No delay in surgery or adverse consequence to the patient was reported.It is unknown if another blade was used to complete the surgery.Concomitant devices reported: tfna fem nail ø10 125° (part# 04.037.012s, lot# unknown, quantity 1).Connecscr f/insertion handle (part# 03.037.010, lot# unknown, quantity 1).Insert-handle hybrid (part# 03.037.011, lot# unknown, quantity 1).Aim-arm 125° f/stat+dyn dist lock (part# 03.037.114, lot# unknown, quantity 1).Buttress/compr-nut (part# 03.037.016, lot# unknown, quantity 1).Guide sleeve yell (part# 03.037.017, lot# unknown, quantity 1).This report is for one (1) unknown tfna helical blade.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A review of the provided x-ray was completed.Provided x-ray was reviewed but the complained issue (the procedure was ended as the tip of the blade was slightly protruded from the outer cortical bone) could not be confirmed as only one image was sent and the complained issue is not clearly visible.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.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7155038
• MDR Text Key: 96126861
• Report Number: 8030965-2017-51019
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1