MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTSCR F/PFNA BLADE

Catalog Number 03.010.411

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: surgeon reported a damaged proximal femoral nail antirotation (pfna) removal scheduled for (b)(6) 2013.It was noted that the original insertion procedure, date unknown, had significant difficulties with the pfna mechanism: source: op notes.There has been a problem with extracting the blade.The plan as it stands is to try to remove the blade with our kit, if it comes out to proceed with revision to dhs.If it does not come out then will dislocate femoral head and knock blade out from other side then thr.It was noted: patient experiencing significant pain from the prominent blade.At this time it has been reported the pfna is still implanted in the patient.Additional information has been requested.This is 2 of 3 report for complaint (b)(4).

Manufacturer Narrative

Additional narrative: device is used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to a device marketed in the usa.Investigation is on-going.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.The manufacturing documents were reviewed and no complaint related issues were found.Placeholder.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device name: hwc.Device is an instrument and is not implanted/explanted.The visual inspection of the returned extraction screw for proximal femoral nail antirotation (pfna) blade by the complaint handling unit revealed the tip is broken off.The broken fragment was not send for evaluation.The relevant dimensions next to the breakage were checked and no deviation was found.The manufacturing documents were reviewed and it was found that the correct material was used and as well the hardness was within specification.The fracture face is homogenous, which indicates material conformity.The complaint condition is likely the result of a mechanical overload during the blade extraction causing the breakage of the extraction screw.Placeholder.

• Brand Name: EXTRACTSCR F/PFNA BLADE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3655198
• MDR Text Key: 4317951
• Report Number: 8030965-2014-00397
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2013

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 7795493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention