MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number 313.930

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Patient age is reported to be between four and sixteen years.Date of event is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address is unknown.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.(b)(4).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 europe reports an event in (b)(6) as follows: it was reported that during a planned removal surgery, on an unknown date, the surgeon had difficulties removing a femoral screw.The screws had been implanted for 8 months.The screwdriver failed, and a second screwdriver was used, although additional force was necessary.The surgery was successfully completed with a reported delay of five to sixty minutes.Patient outcome was reported as okay.The surgeon, who specializes in surgery for children, has developed a technique to correct valgus/varus legs with the depuy synthes cannulated screws.He places the screws percutaneously through the growth plate so it can no longer grow and that the correction will happen in a natural way.The screws remain in the patient for approximately 8 to 24 months.The surgeon has refined this technique in such a manner that he doesn't put the screws maximally to the cortex; no callus would grow around the head of the screw (as this would be a possible cause of difficult extractions).However, currently he's experiencing some difficult extractions.Concomitant devices: 6.5mm cannulated screw fully threaded 105mm (part: 208.477, lot: 9238849, quantity: 1), cannulated screw (part: unknown, lot: unknown, quantity: 1).This report is for a 4.0mm hexagonal screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM HEXAGONAL SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7624674
• MDR Text Key: 112346741
• Report Number: 8030965-2018-54477
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819074026
• UDI-Public: (01)07611819074026
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 313.930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• 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