MAUDE Adverse Event Report: SYNTHES ELMIRA 2.8MM THREADED GUIDE WIRE - TROCAR POINT 300MM; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Catalog Number 292.68

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

Patient Problem No Code Available (3191)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) is used to capture the reported event required medical/surgical intervention to preclude permanent damage to a body structure.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

It was reported during an initial surgery on (b)(6) 2017 for a percutaneous pinning of the patient¿s left femur with three (3), 7.3 mm cannulated screw there was an intraoperative event.During preparation for implantation of the three (3) 7.3 mm cannulated screw into the patient¿s femoral neck bone, a non-cannulated driver shaft was used in conjunction with a guide wire and a power drive.The technician incorrectly provided a non-cannulated solid driver shaft assembly to the surgeon.Due to this, the surgeon over inserted the guide wire more medially into the patient¿s femur head through the acetabulum and advanced into the patient¿s abdomen.Approximately 25 to 50 percent of the guide wire was inserted into the patient¿s abdomen.Surgeon removed the guide wire with a rongeur instrument that was available in the operating room.The removal of guide wire caused an additional 60- 90 minutes surgery delay.A cannulated driver shaft is needed when using a cannulated screw however a cannulated driver shaft was not available in the set and the surgeon contacted the sales consultant to provide one.Surgeon then proceeded with surgery and implanted the three (3) cannulated screws using the correct cannulated solid driver shaft assembly which was made available by the sales consultant.Surgery was completed successfully and patient is reported to be in stable condition.No additional information available.Concomitant devices reported: unknown power drive (part number unknown, lot number unknown, quantity 1) this report is for one (1) 2.8mm threaded guide wire - trocar this is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.8MM THREADED GUIDE WIRE - TROCAR POINT 300MM
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6778227
• MDR Text Key: 82469634
• Report Number: 3003506883-2017-10155
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

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: 292.68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/09/2017
• 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
• Patient Age: 102 YR
• Patient Weight: 112