MAUDE Adverse Event Report: SYNTHES USA 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 13MM; PLATE, FIXATION, BONE

Catalog Number 02.130.013

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Not implanted or explanted, device broke intra-operatively and shaft remains in patient's body.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 while using a screwdriver to place a 1.3mm cortex screw during surgery on (b)(6) 2016, the head of the screw broke upon final tightening.The surgeon elected to leave the shaft of the screw in the patient.The head of the screw was easily identified and removed.There was no surgical time delay and the procedure was completed successfully.Patient outcome following surgery was reported as stable.This complaint involves 1 device.Concomitant device reported: screwdriver (part# unknown, lot# unknown, quantity 1) this report is 1 of 1 for (b)(4).

• Brand Name: 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 13MM
• 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: 5994025
• MDR Text Key: 56333456
• Report Number: 2520274-2016-14761
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.130.013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• 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
• Treatment: SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY
• Patient Outcome(s): Required Intervention