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

Catalog Number 18230015S

Device Problems Break (1069); Collapse (1099)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2018

Event Type  malfunction  

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 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
• Type of Device: IMPLANT
• 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: 7756162
• MDR Text Key: 116702303
• Report Number: 0009610622-2018-00528
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 18230015S
• Device Lot Number: K035F5F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/07/2018 Patient Sequence Number: 1