MAUDE Adverse Event Report: SYNTHES USA CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number 309.530

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2008

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following literature article, bae j., hur c., oh c., oh j.(18 october 2008).Technical difficulties of removal of locking screw after locking compression plating.Arch orthop trauma surg, volume 129, pages 91-95.From (b)(6) 2004 to (b)(6) 2007, the reporters removed 159 5.0-self tapping locking screws, 279 3.5-self tapping locking screws, 198 ao-3.5 cortical and 4.0 cancellous screws from various sites for a total of 58 patients.For 50 patients locking compression plates (lcp, synthes, (b)(4)) were removed after solid union.For eight patients, plates were taken out before union due to acute postoperative infection in two patients, late onset infection in three patients, a revision of the malalignment in two patients and revision of nonunion in one patient.A total of 24 3.5-self tapping locking screws were removed with many difficulties due to the stripping of the hexagonal recess.Conical screw extraction sets were used to remove these screws.Only four stripped screws were removed using a 2.5 conical extraction screw (part 309.521 and part 309.530) in the first attempt.Two additional stripped screws were removed using a 3.5 conical extraction screw.Many difficulties were experienced for the removal of remaining 18 stripped screws.Screws were removed by bending the plate over the hole fixed with stripped screw, the locking hole was deformed as the plate was bent around that hole and the stripped screws were dislodged from the hole and were then removed using vice-grip; plate was cut with a high-speed metal cutting saw for remaining most of the remaining stripped screws; and bending of the plate at the stripped screw and removal of screw by rotating the plate around the screw.One of the 3.5-cortical screws was stripped at the time of removal, the plate was removed after destroying the screw head and the shaft of the screw was left within the bone.This is report 5 of 6 for (b)(4).This report is for a conical extraction screw for large screws and 4.9mm bolts.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The device is an instrument and is not implanted/explanted.This report is for a conical extraction screw for large screws and 4.9mm bolts/quantity 1/unknown lot.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number was provided.Conical extraction screw for large screws and 4.9mm bolts which would not function as described.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4637449
• MDR Text Key: 5611217
• Report Number: 2520274-2015-12283
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1