MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 17965035S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

Due to a "petrochanteric" multi-fragment fracture of the right thigh a gamma nail 3/180 was implanted on (b)(6) 2016.The nail itself does not cause any problems but allergic reactions occur.

Event Description

Due to a petrochanteric multi-fragment fracture of the right thigh a gamma nail 3/180 was implanted on (b)(6)2016.The nail itself does not cause any problems but allergic reactions occur.

Manufacturer Narrative

The reported event that locking screw, fully threaded s2 ø5x35 mm was alleged of [adverse impact on patient / patient related / iatrogenic issue] could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.According to received information the patient complained ¿itching¿ approx.Two years after initial implantation.Furthermore, the confirmation that the present itching was material caused was not confirmed so far by a dermatologist.The current case was forwarded to a hcp for a medical statement [his comments]: ¿a connection with the inserted nail and the presence of an allergic reaction cannot, of course, be completely ruled out.However, the likelihood that the nail is the cause of the reported event is extremely unlikely.In my view, this would be an exclusion diagnosis.If all the relevant, significantly more likely causes, such as a reaction to a drug or a food intolerance reaction or contact allergy from a particular garment or the use of a new detergent or are also excluded from cosmetics and other conceivable causes are out of the question, then you could think about the nail as a cause.The situation is such that the nail is completely embedded after that implantation duration (assuming an undisturbed healing).A release of material from the nail is probably only available to a minimal extent.In the stable situation, there is also no abrasion that would cause exposure to the components or substances that make up the nail.Again, in summary, the nail can almost be excluded as the cause of the described complaints at first.¿ ifu l22000007 refers under chapter ¿contraindications¿: ¿ material sensitivity, documented or suspected.¿ other medical or surgical conditions which would preclude the potential benefit of surgery.¿ ¿adverse effects¿: ¿in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: material sensivity reactions in patients following surgical implantation have rarely been reported, however their significance awaits further clinical evaluation.¿ with available information the event was not caused by any deficiency of the device.In this case it could not be excluded that the case is being patient related but an exact root cause could not be determined.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.Regarding additional customer questions please refer to section ¿additional document review¿.

• Brand Name: LOCKING SCREW, FULLY THREADED S2 Ø5X35 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8171049
• MDR Text Key: 130552535
• Report Number: 0008031020-2018-01068
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540399724
• UDI-Public: 04546540399724
• Combination Product (y/n): N
• PMA/PMN Number: K032579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 17965035S
• Device Lot Number: K032DDF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other