MAUDE Adverse Event Report: SYNTHES HAGENDORF COMPLETE RADIOLUCENT INSERTIONHANDLE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.012

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem Sedation (2368)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

Patient initials ¿ (b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review - manufacturing location: (b)(4).Manufacturing date: 01.Dec.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this 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

It was reported that two (2) guidewires became bound in a stepped drill bit, and there was difficulty removing the connecting screw from the nail and the insertion handle during a trochanteric fixation nail-advanced (tfna) surgery on (b)(6) 2015.During the surgery, the guide wire for the helical blade was inserted through the guide in normal fashion.The wire was measured and a 10mm tapered drill bit was used to perforate the lateral cortex.The stepped drill bit was then set to the correct length and drilled over guide wire.During this, the guide wire was driven out of femoral head and into the acetabulum.The guide wire remained bound in the stepped drill bit.When stepped drill bit was removed, the surgeon lost reduction and had to re reduce and put in another guide wire and perform the previous steps.When inserting stepped drill but, the guide wire became bound again and was driven 50% into the pelvic ring.The surgeon then removed the guide pin quickly and consulted general surgery to check for any damage to the bladder or colon.No known problems were immediately recognized (follow-up review is planned).Due to the risk of driving the pin any further into pelvis, the surgeon stepped reamed and inserted the helical blade without the guide wire.Subsequent to this event, when the surgeon attempted to disconnect the nail from the insertion handle, the surgeon experienced great difficulty unscrewing the cannulated connecting screw from the nail.The screwdriver was reportedly slipping in the connecting screw.It was able to be removed without additional intervention.There was no known harm to patient and the surgery was successfully completed.There was a total delay of thirty minutes.This is report 8 of 8 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation action was conducted/performed.The report indicates: the insertion handle (03.037.012), was received at the investigation site.The hole and shoulder where the connecting screw interfaces seem intact.The features for connection to the nail are intact and functional.Both feature groups are slightly worn due to reuse, but not misuse.It was reported that during a trochanteric nail fixation system (tfna) procedure, the surgeon was unable to disconnect the insertion handle (03.037.012) from the nail after successful nail implantation.It was reported that the t-handled ball hex driver slipped in the head of the connecting screw, and that the surgeon mentioned stripping of the screw head.Visual inspection reveals minor scratches (as expected from a reusable part) but otherwise no damage to the insertion handle.A nail available at the investigation site was used to check the interface between the insertion handle, screw, and nail.The connecting screw was tightened and loosened from the nail without unexpected difficulty.The difficulty experienced by the surgeon when disconnecting the screw could have been because the screw driver was not seated completely.If this was the case, the screw driver would be able to slip as if it was stripping.Additionally, the screw could be held more tightly in place due to dried blood and tissue in the interface.If the screw was tightened hard at first, then tissue entered the interface during implantation, the removal torque may have been increased.Another contributing factor is the material residue on the screw thread.If the material was present when the connection was tightened, it could have jammed in the connection and increased the torque required to remove the screw.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.

• Brand Name: COMPLETE RADIOLUCENT INSERTIONHANDLE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5354318
• MDR Text Key: 35452195
• Report Number: 3003875359-2016-10011
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.012
• Device Lot Number: 9194891
• Other Device ID Number: (01)10886982070289(10)9194891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75