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

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.510(k): report is for one (1) unknown cannulated screw.Other: udi: part number unknown, lot number unknown; udi unknown (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

It was reported that the thread of 4.5mm cannulated screw stripped off inside a patient.The x-rays confirmed presence of the threads in the patient's bone.Surgeon reportedly attempted to retrieve the screw metal threads from the patient, however the pieces of the thread remained in the bone after the surgery.It is unknown if there was surgical delay and no additional intervention was reported.This report is for one (1) unknown cannulated screw.This is report 1 of 1 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• 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: 5370153
• MDR Text Key: 36080522
• Report Number: 2520274-2016-10252
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• 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?: No
• Date Manufacturer Received: 12/29/2015
• 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