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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypovolemic Shock (1917)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown tfn nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not reported to have been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(4) reports an event in (b)(6) as follows: it was reported patient presented on an unknown date with transtrochanteric fracture and multiple unidentified comorbidities which required rapid surgical intervention.A trochanteric fixation nail advanced (tfna) procedure was scheduled.It is unknown when it was discovered that there were no tfnas available.It was then decided to use the trochanteric fixation nail (tfn) product.During the tfn procedure, surgeon attempted multiple times to insert the helical blade but was not successful.It was then noted the tfn nail¿s locking mechanism was pre-deployed.Surgeon removed the nail and backed out the locking mechanism, then re-inserted the nail and was then able to insert the helical blade.Patient experienced blood loss and was reported to have gone into shock.Surgery was completed with a delay of approximately two and one half (2 ½) hours.Concomitant device reported: tfn helical blade (part number unknown, lot number unknown, quantity 1).

• 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: 7421185
• MDR Text Key: 105147336
• Report Number: 8030965-2018-52973
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 01/17/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 04/11/2018
• 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