MAUDE Adverse Event Report: SYNTHES ELMIRA HELIX BLADE 115MM; APPLIANCE,FIXATION,NAIL

Catalog Number 282.242

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 04/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional device product codes used jdo.(b)(4).Event occurred intraoperative on (b)(6) 2017.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).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 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

It was reported that a patient underwent an unknown procedure on (b)(6) 2017.When the surgeon attempted to seat the barrel over the blade with the impactor, the blade advanced through the patient's femoral head and became stuck inside the dynamic helical hip system (dhhs) barrel.There was a delay of 30 to 45 minutes to complete the surgery.The surgeon attached the threaded extractor from the dhhs set and used a slotted hammer to remove the blade.Since it was stuck, the blade and barrel had to come out as a unit.Another blade with the same part number was used to complete the rest of the surgery successfully and without further issues.The patient's status was stable.No additional information available.Concomitant medical products: 135 degree dhhs 3 hole standard barrel plate (part# 282.611, lot# 5061320, quantity 1); impactor (part # unknown, lot # unknown, quantity 1).This report is for one (1) helix blade 115mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.A visual inspection, functional test (technique guide review) and drawing review were performed as part of this investigation.The complaint condition is confirmed.The helix blade and the side plate were received stuck together.Minor deformation of the hexagonal recess of the helical blade was observed which could have occurred due to intraoperative driving and retrieval forces.The returned instruments were examined by customer quality upon receipt.Relevant drawings were reviewed.The outer diameter (od) and the width between flat to flat surfaces of the proximal end of the helix blade shaft that meets with the side plate were measured.Helix blade outer diameter was measured as 7.11mm (specification: 7.15 +0/-0.05) and flat to flat width was measured as 7.88mm (specification 7.9+0/-0.05).Ca301 used for all measurements.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Synthes technique guide for lcp dhhs system was reviewed.It says ¿do not use the cap for impactor and shaft guide to seat the plate if the plate is more than 5 mm off the bone.If the plate appears to be more than 5 mm off the bone, the flats on the helix blade and the internal flats on the key may not be properly aligned.Impacting the plate in this condition could cause further unwanted advancement of the helix blade.¿ additionally it says ¿use of light blows with the hammer is recommended until the side plate is seated completely against the lateral cortex.¿ it is possible that not following any of the above two technique instruction could have led to the complaint condition.The exact root cause could not be determined in this case.It is possible that the user did not follow the user instructions/technique guide which could have led to the complaint condition.There is no evidence of a manufacturing issue and no product design issues or discrepancies were observed that may have contributed to the complaint condition.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

Upon customer quality engineer investigation, it was determined that initially reported as concomitant device, 135 degree dhhs 3 hole standard barrel plate (part# 282.611, lot# 5061320, quantity 1) should be added as a part data since it cannot be ruled out as not contributing to the complaint condition.This is report 1 of 2 for (b)(4).

• Brand Name: HELIX BLADE 115MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6566388
• MDR Text Key: 75143624
• Report Number: 3003506883-2017-10080
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 282.242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN IMPACTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR