MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP T2 TIBIA Ø8,+15MM; IMPLANT

Catalog Number	18230015S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The patient underwent t2 tibia surgery on (b)(6) 2017, and the removal surgery was performed on (b)(6) 2018.When the end cap was attempted to be removed with a driver but the head of the end cap collapsed.Therefore, the conical extractor was used to removed the end cap but the tip of the extractor broke in the head of the end cap, and the broken tip could not be removed.The surgeon tried to removed the end cap but it completely stuck in the nail, so only locking screws were removed and the nail removal surgery was gave up.Broken fragment remaining.
Additional Manufacturer Narrative
The reported event that end cap t2 tibia ø8,+15mm was alleged of 'implant - breakage / deformation - other' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Product inquiry states the conical extractor to be the subject product.The device was used to extract a stryker end cap t2 tibia which wasn't reported to be broken according to the event description.No further associated products were reported.During investigation no material, design or manufacturing related issues were found.The tip of the conical extractor received is completely broken off.The breakage surface indicates a (forced) brittle fracture of the device due to a bending overload.To prevent this, the extractor is laser-marked with the warning ¿do not lever¿.Hardened materials are brittle and rather break than bend.Therefore it is not allowed to bend the extractor i.E.Using it as lever arm.According to test report # 160506hk1 the axial pull-off strength and transmittable torque was tested as follows: ¿with all screw extractors an axial tensile force of 20n could be transmitted without separating the conjunction between screw extractor and screw ¿¿ ¿as the screw extractor sw3,5 is hitting the ground of the screw head with its front surface it can only transmit low moments of torque such as 1,2nm up to 1,9nm.After a modification (shortening of the crest of thread by 1,5mm)at the screw extractor the transmittable torque was between 8,1nm (screw twisted off) up to 1,2nm (breakage of screw extractor).¿ nevertheless, the achieved moment of torque is regarded as sufficient as the screw-in ¿ and breakaway torque for bone screws generally does not exceed 5nm.¿ based on the above facts it can be ascertained that the root cause of the reported event is not related to a deficiency of the device, but is rather linked to an inadequate handling by the user.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient underwent t2 tibia surgery on (b)(6) 2017, and the removal surgery was performed on (b)(6) 2018.When the end cap was attempted to be removed with a driver but the head of the end cap collapsed.Therefore, the conical extractor was used to removed the end cap but the tip of the extractor broke in the head of the end cap, and the broken tip could not be removed.The surgeon tried to removed the end cap but it completely stuck in the nail, so only locking screws were removed and the nail removal surgery was gave up.Broken fragment remaining.

• Brand Name: END CAP T2 TIBIA Ø8,+15MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7756162
• Report Number: 0009610622-2018-00528
• Device Sequence Number: 1012819
• Product Code: HSB
• UDI-Device Identifier: 04546540369369
• UDI-Public: 04546540369369
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 18230015S
• Device Lot Number: K035F5F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR