MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.290S

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

Patient Problem No Code Available (3191)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 a procedure to implant the trochanteric femoral nail-advanced (tfna) was performed on (b)(6) 2017.To insert the tfna helical blade, surgeon drilled the bone head with a 6mm/9mm cannulated stepped drill bit.Due to patient¿s robust bone quality, the torque limiter for the handpiece was utilized, preventing surgeon from drilling up to the targeted position.When the helical blade was passed through the fractured area, the surgeon released traction.At that time, the fractured area began separating.Surgeon manually pushed soft tissue around the guidewire sleeve.After turning a buttress compression nut counterclockwise, surgeon inserted a guidewire sleeve along the outer cortex and rehammering was performed.When the hammering was completed, it was noted that the fractured area had separated more than 5mm, leading to valgus of the fractured area.This resulted in the helical blade being placed approximately 5mm short of the targeted position.Surgeon locked only the blade and then closed the incision, leaving the blade protruding 5mm.Surgery was completed successfully with a delay of approximately 15 minutes.Concomitant devices reported: blade/screw guide sleeve (03.037.017, lot number unknown, quantity 1), buttress/compression nut (03.037.016, lot number unknown, quantity 1), 9mm/125 degree titanium cannulated tfna 235mm/right (04.037.914s, lot number unknown, quantity 1) this is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 90MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7153458
• MDR Text Key: 96005247
• Report Number: 8030965-2017-50996
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652446
• UDI-Public: (01)07611819652446(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• 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
• Report Date: 11/30/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR