MAUDE Adverse Event Report: SYNTHES, USA TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.290S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(6).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 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 (b)(4) reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, the surgeon found that the blade had cut out.He explanted the blade and performed artificial bone head surgery on (b)(6) 2016.Surgeon had confirmed that the blade was cut out in the image taken on (b)(6) 2016.Patient underwent initial implant procedure on (b)(6) 2016, for the femur trochanteric fracture.Events occurred during the initial surgery is captured in (b)(4).Concomitant device: tfna fem nail o 12 r 130° l320 timo15 (part # 04.037.252s, lot # unknown, quantity: 1).This report is for one (1) tfna helical blade.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 90MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 6096351
• MDR Text Key: 59719237
• Report Number: 2520274-2016-15354
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• 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: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.038.290S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/11/2016
• 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: PART # 04.037.252S, LOT # UNKNOWN, QUANTITY: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR