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

Catalog Number 03.037.030

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.The subject device is currently undergoing investigation; the results are pending completion.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: mar 19, 2015.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported patient was implanted with the proximal femoral nailing system (tfna) on unknown date at a different facility by a different surgeon for compression of a femoral head fracture.As the fracture compressed over time, the helical blade began to protrude beyond the bone, causing the patient discomfort.Patient was returned to surgery on (b)(6) 2016 for retraction of the helical blade.As surgeon was completing final tightening on the helical blade, it is reported he felt some resistance, and then turned the helical blade extractor one more turn.In doing so, the tip of the helical blade extractor broke off into the end of the helical blade.The fragment was not retrieved and remains embedded in the implanted helical blade.Helical blade was not retracted.The surgery was completed successfully with no delay and no further harm to patient.The helical blade retraction is addressed in related complaint (b)(4).This complaint addresses the helical blade extractor breakage.Concomitant devices reported: helical blade (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.This complaint is confirmed.Upon visual inspection, the complaint condition is confirmed as the distal tip has sheared off from the rest of the device and was not returned.The balance of the device is in fair condition with minimal signs of wear and tear.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.A visual inspection under 5x magnification and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The returned implant is part of the depuy synthes tfn advanced (tfna) proximal femoral nailing system.The helical blade/screw extractor is used to remove an implanted helical blade/screw (per technique guide).A review of the current design drawing was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Unable to determine a definitive root cause.Most likely due to application of excessive force during threading/insertion into the implanted helical blade due to bony ingrowth around the helical blade.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: 6132795
• MDR Text Key: 61059766
• Report Number: 3003875359-2016-10620
• Device Sequence Number: 1
• Product Code: HSB
• 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: 11/04/2016

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
• Device Catalogue Number: 03.037.030
• Device Lot Number: 9376543
• Other Device ID Number: (01)10886982070463(10)9376543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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: UNKNOWN (TFNA) HELICAL BLADE, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 64