MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Date of device migration is not known.This report is for an tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant reported as approximately two (2) years prior to removal.Date of explant is not known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 follows: it was reported patient underwent initial trochanteric femoral nail advanced (tfna) implant surgery for a femoral trochanteric fracture approximately two (2) years prior to removal.It was further reported that the helical blade was not fully inserted during the initial procedure and the locking mechanism on the nail may not have properly functioned.After bone adhesion, patient complained of pain in the hip.It was determined the helical blade had protruded frontward.Removal surgery was performed on an unknown date and completed successfully with no further issue.Intraoperative issues during the initial procedure are addressed in (b)(4).This report addresses the migration of the helical blade that lead to the removal surgery.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.This complaint was re-reviewed due to the investigation findings.The nail locking mechanism component was identified to be broken.During the initial procedure the nail did not function properly and the blade was not fully inserted.It was determined that the intra-operative malfunctions caused or contributed to the reported post-operative consequences that resulted in the blade migrating post-operative and pain.It is assumed that the locking mechanism component was broken and that is why during the initial procedure that it was not ¿working properly¿.This event will be captured as one complaint under complaint (b)(4).This complaint (b)(4) will be voided.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.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7142101
• MDR Text Key: 95616909
• Report Number: 8030965-2017-50946
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention