MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA BLADE L110 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.718S

Device Problem Break (1069)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.It is unknown when the patient¿s symptoms began.The pfna blade was broken during the (b)(6) 2009 surgery.(b)(4).The subject is not expected to be returned to the synthes manufacturer for evaluation.510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: feb 25, 2008.Expiration date: feb 1, 2018.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in france as follows: it was initially reported on august 5, 2011 that the patient was implanted with a proximal femoral nail antirotation (pfna) was implanted on (b)(6) 2008 to treat an impacted fracture in the upper end of the left femur sustained during a car accident.On (b)(6) 2009 the patient revision surgery with hardware removal was attempted at a different hospital.For this procedure, the hospital obtained a synthes loan set for pfna removal.During the (b)(6) 2009 procedure, the pfna blade broke and the surgeon could not remove the material.The surgeon opted to close the patient with the broken blade and intact nail retained in the patient.A broken drill bit fragment was found in the patient¿s leg and a damaged screw was also found.These devices were also not removed.The goal of the operation was not achieved, since the material had not been removed.Whereas soon after the procedure, the patient felt like the material was being displaced, which heightened his pain and prevented him from remaining in a standing position for long.These events were addressed and reported in (b)(4)12080.These complaint handling systems were used by synthes at the time of the initially reported complaint.The associated medwatch reports are (b)(4).Additional information was received on february 9, 2017 and february 16, 2017.It was further reported that the patient initially underwent the (b)(6) 2009 revision surgery to remove the pfna implants due to pain and discomfort.The part and lot number of the pfna blade were provided.It was also reported that the failure to remove the osteosynthesis resulted in moderate pain in the outer surface of the left thigh, which is related to the protruding osteosynthesis nail head implant.This slight protrusion has produced moderate rubbing against the fascia lata and could be the source of the moderate pain.In addition this complaint further addresses the unknown broken drill bit and unknown damaged screw.Please also see related complaint (b)(4).Concomitant medical products: 472.261s, pfna nail, lot 2106892, qty 1.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on february 9, 2017 and february 16, 2017.It was further reported that due to the broken drill bit, the surgeon was obliged to install a simple unicortical, rather than a bicortical screw.The complaint indicated that initially the damage to the screws was not known.The surgeon performing the explant of the pfna discovered that the patient¿s implant was significantly damaged.The surgeon stated that there was "difficulty in removing lower locking screw since screw head was destroyed.Neck screw was found to be disengaged.Extender installed in order to remove screw; however, additional problem observed since screw heads were destroyed and extracting device does not hold the end of the neck screw.The surgeon attempted to remove the nail, but experienced difficulty doing this.Since the neck screw cannot be removed, nor can the medullary nail.¿ concomitant reported devices: 472.261s, pfna nail, lot 2106892, qty 1.Removal instruments, part and lot unknown, qty unknown.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (pfna blade l110 tan, part number 456.718s, lot number 2342121).The subject device was returned with the complaint condition stating: only x-rays provided.The reported issue can't be analyzed with precision as no material has been provided.However, after having reviewed the available x-rays following assumptions can be made: - the blade was inserted with an impactor not fully engaged, leading to a deformation of the thread of the blade.- the blade could not be locked.- during the material removal the removal instrument could not properly engage the blade and only the cover (tip) of the blade could be removed, probably by using the wrong instrument.Both the products and the surgical technique needed for the removal of the blade were available at the date the removal surgery was performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFNA BLADE L110 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6390360
• MDR Text Key: 69438148
• Report Number: 9612488-2017-10102
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 456.718S
• Device Lot Number: 2342121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2017
• Date Device Manufactured: 02/25/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 472.261S, PFNA NAIL, LOT 2106892, QTY 1
• Patient Outcome(s): Required Intervention