MAUDE Adverse Event Report: SYNTHES HAGENDORF HELICAL BLADE/SCREW EXTRACTOR; ROD,FIXATION,INTRAMEDULLARY

Model Number 03.037.030

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Concomitant device therapy date is not known.Subject device has been received and is currently in the evaluation process.Dhr review was completed.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site: (b)(4).Manufacturing date: 06.Feb.2015.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 during a trochanteric fixation nail (tfn) removal of the left hip on (b)(6) 2017 for protrusion and irritation of the lag screw, the surgeon was able to get the locking mechanism out of the proximal end of the nail and while using the blade screw extractor to remove the lag screw the threaded tip of the blade/screw extractor snapped off.The surgeon tried to retrieve it but was unable and left it in the patient with the tfn.The original implant date is unknown.There was a total of an hour delay in surgery.The surgery was less than successful.The unknown lag screw that protruded and caused irritation is addressed in (b)(4).This report addresses the blade/screw extractor that broken intraoperatively.Concomitant devices reported: lag screw (quantity 1).This report is for one (1) helical blade/screw extractor.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: a visual inspection under 5x magnification, drawing review, and dhr review were performed as part of this investigation.This complaint is confirmed.The locking tip on the distal end of the device is broken and missing.Missing fragment was left in the patient.Whether this complaint can be replicated is not applicable for this complaint condition as the returned device is already damaged.No new malfunctions were identified as a result of the investigation.The returned helical blade/screw extractor is a reusable instrument available for use tfna system.The locking tip on the distal end of the device is broken and missing.Missing fragment was left in the patient.The overall balance of the device looked in a good condition with minimal surface wear.A review of the current design drawing and available history for the top level drawing for the screwdriver was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The device¿s application involves use of hammer.Most likely due to application of excessive and/or off-axis force during threading/extraction of the implanted helical blade due to boney ingrowth around the helical blade.Improper hammering technique could also contribute to the complaint condition.In the absence of the further details regarding the surgery, it is not possible to determine the exact root cause of the issue.No non-conformance reports 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.This indicates that all the manufacturing processes were followed as per requirement ensuring product material and hardness at the time of manufacturing.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: HELICAL BLADE/SCREW EXTRACTOR
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6797141
• MDR Text Key: 82782008
• Report Number: 3003875359-2017-10400
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070463
• UDI-Public: (01)10886982070463(10)9354791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.030
• Device Catalogue Number: 03.037.030
• Device Lot Number: 9354791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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
• Treatment: LAG SCREW (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR