MAUDE Adverse Event Report: SYNTHES USA 1.5MM TI LOCKING SCR SLF-TPNG WITH T4 STARDRIVE RECESS 8MM; PLATE,FIXATION,BONE

Catalog Number 04.214.008

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).(b)(6).Device broke intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn.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 on an event in (b)(6) as follows: it was reported that while procedure: open reduction internal fixation finger.Surgeon reported during a conversation that the head of a 1.5mm cortex screw (titanium) twisted off during insertion.It was unclear if it was during the final tightening or actual insertion.The remainder of the screw was left in the patient.He also reported that he was required to remove a 1.5mm locking screw and the screw recess became damaged and the screw was unable to be removed.He noted that there was no specific removal instrumentation for the t4 stardrive recess if it became damaged.He needed to bend the plate and use it as a handle to remove the plate.Surgical delay was experienced as a result, exact surgical delay unknown.No reported adverse event to patient.This complaint involves two devices.This report is 2 of 2 for (b)(4).

• Brand Name: 1.5MM TI LOCKING SCR SLF-TPNG WITH T4 STARDRIVE RECESS 8MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5948372
• MDR Text Key: 54627101
• Report Number: 2520274-2016-14518
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.214.008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• 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