MAUDE Adverse Event Report: SYNTHES USA PFNA-II Ø12 XS 130° L170 TAN; PFNA-II 012XS 130 DEGREES

Catalog Number 472.107S

Device Problems Fitting Problem (2183); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed.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: surgery for femoral trochanteric fracture took place on (b)(6) 2016.During the surgery, the reported pfna (proximal femoral nail antirotation) japanese was applied for the patient's femur.The patient complained a pain in the operated area during the rehab.Then, x-ray was taken on (b)(6) 2016., and it revealed that the tip of the reported blade had been penetrated from the patient's femoral head.The patients still has the pain in the hip joint and difficult to perform the hip flexion.Besides, frictional sound has come from the operated part of the patient.The surgeon will have a meeting with the patient on (b)(6) 2016, to decide whether the revision will be held or not.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional product code: hwc.(b)(4).(b)(6).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.

• Brand Name: PFNA-II Ø12 XS 130° L170 TAN
• Type of Device: PFNA-II 012XS 130 DEGREES
• 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: 5481550
• MDR Text Key: 39738165
• Report Number: 2520274-2016-11477
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.107S
• Other Device ID Number: GTIN: 07611819837324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• 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
• Patient Age: 90 YR