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

Catalog Number 201.928

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

Device broke intra-operatively and was not implanted / explanted.(b)(4).(b)(6).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.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 eu reports an event in (b)(6) as follows: while inserting the 8mm inter-medullary fixation (imf) screw using standard surgical technique and standard instrumentation the screw sheared off and broke leaving a screw fragment in the patient's mandible without any screw head attached.The surgeon had difficulty trying to remove the fragment.Reportedly the surgeon initially experienced several failed attempts to retrieve the fragment using items from the depuy synthes cmf small screw removal set and damaged screw removal set; however surgeon was able to remove by extra drilling around the fragment in order to loosen it.There was approximately 30 minutes surgical delay.This is report 1 of 1 for com-(b)(4).

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5035098
• MDR Text Key: 24288123
• Report Number: 2520274-2015-15529
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention