MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø10X255 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18221025S

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that during t2t extraction surgery, it took a long time to remove an end cap.The end cap could be loosen with a driver, but it did not reach removal.The end cap seemed to stuck to the nail.The surgeon used a conical extractor, pliers and a hummer, and removed the end cap forcibly.After that the surgeon tried to remove the nail, but it could not be removed due to the bone quality of the patient.The surgeon wants the investigation of the thread of the end cap.The primary surgery was performed 3-4 years ago.

Manufacturer Narrative

Investigation summary: product inquiry stated the end cap t2 tibia +10 mm and the tibial nail, standard t2 tibia ø10x255 mm to be the subject products.No further associated products were reported.The review of the device history records revealed no discrepancies.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.During investigation no material, design or manufacturing related issues were found.Appearance of deformed / stripped off thread flanks and material displacement as well as clear traces of cross-threading indicate that the end cap likely had been inserted under misalignment by considerable force during the initial surgery.The thread of the nail likely was also damaged (same material as the end cap).But this could not be proofed as the nail was still implanted and therefore not available.A functional test of the end cap revealed that the item could be screwed and unscrewed into a sample tibial nail until its desired end position as intended although the thread being damaged.The reported event (¿the end cap could be loosen with a driver, but it did not reach removal.The end cap seemed to stuck to the nail¿) could not be confirmed or reproduced.A deficiency of the end cap in question was not verified.Referring to additional information received the tibial nail could not be explanted due to bone ingrowth.A similar case had been reviewed by a hcp, who stated that ¿removal of an im nail may be challenge, particularly in younger patients with stable bone structure, significant endosteal callus formation, and distinct remodeling¿im nails made from type ii anodized titanium alloy are biologically inert and there is no particular need to remove non-irritated im nails in general, even in young patients.Forced removal of an im nail with bony ingrowth bears a risk of bone damage.This risk should be outweighed against a possible theoretical marginal advantage of nail removal¿¿ in the case that implant removal is required or wished we refer to the extraction kit.In case of request experienced engineers from the manufacturer would assist.With available information and with still implanted item no further technical statement was possible.In case relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.With received information it was suggested that the event was not related to a deficiency of the devices, but was most likely patient related.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.Device remains implanted.

Event Description

It was reported that during t2t extraction surgery, it took a long time to remove an end cap.The end cap could be loosen with a driver, but it did not reach removal.The end cap seemed to stuck to the nail.The surgeon used a conical extractor, pliers and a hummer, and removed the end cap forcibly.After that the surgeon tried to remove the nail, but it could not be removed due to the bone quality of the patient.The surgeon wants the investigation of the thread of the end cap.The primary surgery was performed 3-4 years ago.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø10X255 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5139932
• MDR Text Key: 28261423
• Report Number: 0009610622-2015-00470
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 18221025S
• Device Lot Number: K581634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR