MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.000S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary of product development investigation.The reported event does not describe a dysfunction or a design deficiency but a customer feedback.The modifications requested by the surgeon are not clear or/and not possible to implement for following reasons: make the thread pitch longer¿: pitch / thread of the endcap (pitch and length) is designed to avoid collision with the end of the thread in the nail and with the locking prong.The length of the thread does furthermore have no influence of the ease of insertion of the end cap into the nail.Change the design so that the screw is held with the screwdriver firmly ¿: the screw interface cannot be designed to be firmly hold by the screwdriver as the self-holding feature is on the screw driver side and the ball shape of the screwdriver tip does not allow to have a self-holding feature.The retention of the endcap can be enabled by the use of a guide wire.Change the design so that the acceptable range of the end cap insertion becomes wider¿: the angulation of the screwdriver with the endcap is limited by the cannulation in the screwdriver shaft.Increasing the possible angulation of the end cap with the screwdriver would weaken the screwdriver shaft and / or make the stardrive feature not retained on the shaft.The reported event does not describe a dysfunction or a design deficiency but a customer feedback regarding the function of the products that can't be improved or changed and that where verified and validated.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown surgery a trochanteric femoral nail advanced (tfna) system was applied for femoral trochanteric fractures.During surgery, the surgeon had a difficulty in insertion and tightening an end cap using a screwdriver due to following reasons: (1) the pitch of threads on an end cap is short , thus clearance was small; (2) an end cap was detached from the driver shaft; (3) due to an unknown guide wire with hook, an acceptable range of angle for inserting the end cap was limited; (4) and the tip of the driver shaft could not be bent.So, the surgeon requested to change the design as follows: make the thread pitch longer, change the design so that the screw is held with the screwdriver firmly, and change the design so that the acceptable range of the end cap insertion becomes wider.The procedure was successfully completed with a 30 minutes surgical delay reported.There was no adverse consequence to the patient.Concomitant devices reported: unknown guide wire ( part # unknown, lot # unknown, quantity 1) unknown screwdriver shaft ( part # unknown, lot # unknown, quantity 1).This complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

It was further reported that the surgeon also reported that it was hard to engage the locking mechanism since the handle of a cannulated stardrive screwdriver interfered with the wing of the ilium while inserting a driver shaft.Concomitant devices: guide wire with hook (part unknown, lot unknown, quantity 1).

• Brand Name: TI END CAP FOR TFNA 0MM EXTN - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8283603
• MDR Text Key: 134332806
• Report Number: 8030965-2019-60443
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2019
• Patient Sequence Number: 1