MAUDE Adverse Event Report: END CAP T2 PROX. HUM. Ø10 MM, +4 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1832-0004S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
The following was reported: the x-rays taken two weeks later showed that the endcap was coming off a little, and the x-rays taken seven to eight weeks later showed that it was coming off more than before.The x-rays taken ten months later showed that it was almost removed.At that time, since the fusion was not yet secure, it was decided to observe the patient.In (b)(6) 2021, it was confirmed that the end cap was completely removed.Therefore, the end cap was removed on (b)(6) in revision surgery.The nail was not removed.The patient experienced pain as a result of the event.
Additional Manufacturer Narrative
The reported event could be confirmed, since the damaged thread indicates that there was an issue during insertion.The device inspection revealed the following: the visual inspection has shown the thread flanks are strongly damaged and partially flattened.The anodized layer it worn away at the damages which indicates that they were caused post-manufacturing.The hexagon recess has clearly visible deformations, caused by applying high torque during the insertion.All these damages indicate that the device was exposed to high forces during the insertion.A functional test with a nail, with locking screw and without locking screw was made.It was possible to insert, tighten and remove the end cap without any issues although the thread of the end cap is damaged.Based on that it can be concluded that the end cap is functional as required.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.Based on investigation, the root cause was attributed to a user related issue.The damages indicate that there were high forces required to insert the end cap into the nail, either caused by cross threading or any residues in the bore.Due to this high resistance the end cap insertion was most likely stopped before the cap was fully tightened as required, which did finally lead to the complained failure.If more information is provided, the case will be reassessed.
Event or Problem Description
The following was reported: the x-rays taken two weeks later showed that the endcap was coming off a little, and the x-rays taken seven to eight weeks later showed that it was coming off more than before.The x-rays taken ten months later showed that it was almost removed.At that time, since the fusion was not yet secure, it was decided to observe the patient.In (b)(6) 2021, it was confirmed that the end cap was completely removed.Therefore, the end cap was removed on (b)(6) in revision surgery.The nail was not removed.The patient experienced pain as a result of the event.

• Brand Name: END CAP T2 PROX. HUM. Ø10 MM, +4 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 12280762
• Report Number: 0009610622-2021-00631
• Device Sequence Number: 19762625
• Product Code: HSB
• UDI-Device Identifier: 04546540379764
• UDI-Public: 04546540379764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: 1832-0004S
• Device Catalogue Number: 18320004S
• Device Lot Number: K01A5C9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR