MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.928S

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Without a lot number the device history records review could not be completed.The manufacture date is unknown.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

Device report from synthes (b)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2017, a imf screw was inserted in the bone, occlusion was fixed with wires, plates and screws placed in position.Then wires were cut to remove the occlusion.When removing imf screws, one screw was broken: one half of the screw body was stuck in the bone of the patient and could not be removed.The other fracture with the screw head could be removed.The surgery was prolonged by 5 minutes.Part of the implant still in the bone of the patient, and she feels pain in its location.The final outcome was good, but it would have been successful if the imf screw was removed completely from the bone.It was only the imf screw that was broken.It wasn¿t attached to any other implant.No other medical intervention was needed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.Manufacturer received the imf screw (201.928s / unknown lot) for investigation.The visual investigation has shown that the imf screw is broken off as complained.The threads that remain are in relatively good condition.The screw head is in good condition.Since only one fragment of the screw was returned and no lot number was provided the complaint cannot be fully analyzed neither a review of the device history records could be performed.The relevant dimension of the screw cannot be measured due to its broken off/ damaged condition.A review of the x-ray confirmed the embedded device.Unfortunately the exact reason for this occurrence could not be determined.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6356161
• MDR Text Key: 68272645
• Report Number: 2520274-2017-10593
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN QTY OF UNKNOWN IMF SCREW; UNKNOWN QTY OF UNKNOWN PLATE; UNKNOWN QTY OF UNKNOWN WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR