MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 14MM/130 DEG TI CANN TFNA 460MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.467S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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 (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, the surgeon noted an x-ray of a broken smith and nephew nail and an unhealed proximal femur.Two (2)trochanteric fixation nail-advanced (tfna) with augmentation was planned and order was made.The revision surgery was scheduled for (b)(6) 2018.Prior to revision, while checking if everything was there, it was noted that the received tfna nails were not received.As a result, revision surgery was reschedule to (b)(6) 2018 while inquiries were made about missing nails.Nails were not received by (b)(6) 2018 and the decision was made to go ahead with the surgery.The surgeon had to use a shorter nail because the nails could not be delivered before surgery.As the surgery progressed, it was realized that the optimal nail length and diameter was one of the ones that had not received.However, in the end the surgeon was happy with the result.Patient outcome is unknown.This report is for one (1) tfna nail.This is report 2 of 2 for (b)(4).

• Brand Name: 14MM/130 DEG TI CANN TFNA 460MM/LEFT-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8190382
• MDR Text Key: 131208471
• Report Number: 8030965-2018-59221
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651678
• UDI-Public: (01)07611819651678
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.467S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention