MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.112

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Patient id/initials, age/date of birth and weight are unknown. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 that on (b)(6) 2018, a patient underwent a trochanteric fixation nail advanced (tfna) procedure. During the surgery, the surgeon tried to take off the percutaneous radiolucent insertion handle after having placed and locked down the tfna femoral nail, titanium alloy and lag screw. However, the connecting screw for insertion handle would not release from the nail. The patient¿s leg was abducted and the connecting screw could not be removed. The surgeon then removed the instrumentation and implants. A new second nail of the same part and different sized lag screw were inserted, and another new second connecting screw and insertion handle were used. The same issue occurred. The connecting screw became stuck to the nail while taking off the second insertion handle. The surgeon was able to disengage the connecting screw from the nail. The second nail and lag screw remained implanted in the patient. It was noted that the nail was not fitting on properly, and that the tips of both insertion handles had become bent or torqued. It was also noted that the screw inserter bent at the handle and the helical blade/screw coupling screw bent at the tip of the threads. There was an unknown surgical delay reported. Additional medical intervention was required. The patient outcome was also unknown. The procedure was successfully completed. Concomitant device reported: trochanteric fixation nail advanced (tfna) screw 100mm - sterile (part 04. 038. 100s, lot h406590, quantity 1); trochanteric fixation nail advanced (tfna) screw 110mm - sterile (part 04. 038. 110s, lot 7859799, quantity 1). This is report 5 of 8 for (b)(4).

• Brand Name: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7561408
• MDR Text Key: 109884789
• Report Number: 2939274-2018-52382
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.037.112
• Device Catalogue Number: 03.037.112
• Device Lot Number: 9302804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 06/01/2018 Patient Sequence Number: 1