MAUDE Adverse Event Report: SYNTHES USA TTAP FOR 3.5MM CORTEX SCREWS GOLD/110MM; TAP, BONE

Catalog Number 311.320

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follow: the tapper for 3.5mm cortex screws (instrument) was broken during the procedure on (b)(6) 2016.The broken tapper fragment remained in patient¿s bone.No additional patient harm reported.Patient outcome was reported as good.The procedure was completed successfully.No prolongation of the surgery reported.This report is for one (1) tap for 3.5mm cortex screws gold/110mm.This is report 1 of 1 for (b)(4).

• Brand Name: TTAP FOR 3.5MM CORTEX SCREWS GOLD/110MM
• Type of Device: TAP, BONE
• 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: 6321888
• MDR Text Key: 67110065
• Report Number: 2520274-2017-10445
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention