MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

Device Problem Sticking (1597)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal article.A simple technique for removing a locking compression plate with a stripped locking screw.Kim, seok-jung., kim, min-up., j orthop trauma, volume 26, number 6, june 2012.This is a retrospective review of 2 patients and a straightforward technique to remove a locking compression plate (lcp) and screw with a stripped hexagonal recess.Locking compression plates (lcp; synthes, (b)(4)) are now widely viewed as the standard method for fracture treatment, and some promising clinical reports support this trend.However, along with their increased use, some of their limitations are also becoming evident, especially those regarding their removal.Therefore, we describe a simple, effective method of removing a locking compression plate with a stripped locking screw.If the hexagonal recess of the screw had been stripped during attempts at screw removal using a conical extraction device, we perform the following procedure after loosening the contact surface between the bone and the plate.Using a larger drill bit, another hole is drilled immediately adjacent to the screw through the non-locking portion of the combination hole.The plate is struck along the line connecting the screw to the newly formed hole.Using an elevator, leverage force is then applied to the plate, which can be removed with the stripped screw attached.This technique can be used to remove plates with several stripped screws and does not require any special tools.This report is for a (b)(6) female patient who had a distal tibia fracture and open reduction and internal fixation.One year postoperatively, the patient elected to undergo implant removal as a result of discomfort over the medial malleolus.Removal of the lcp was performed; however, one of the locking screws was stripped.The stripped screw and plate were successfully removed using the described technique.This report is 3 of 4 for (b)(4).This report is for an unknown locking compression plate.

Manufacturer Narrative

Device used for treatment, not for diagnosis.A simple technique for removing a locking compression plate with a stripped locking screw.Kim, seok-jung., kim, min-up., j orthop trauma, volume 26, number 6, june 2012.This report is for an unknown (unknown plate/unknown quantity/unknown lot.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4210214
• MDR Text Key: 4984420
• Report Number: 2520274-2014-14025
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR