MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP, SCN T2 SCN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18260003S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
At (b)(6) 2018, operation with t2scn was done.After the operation, the end cap was came out and the most distal condyle screw was backed out.Therefore, at (b)(6) 2018, the end cap and condyle screw was removed and new same devices were implanted.
Event or Problem Description
At (b)(6) 2018, operation with t2scn was done.After the operation, the end cap was came out and the most distal condyle screw was backed out.Therefore, at (b)(6) 2018, the end cap and condyle screw was removed and new same devices were implanted.
Additional Manufacturer Narrative
The reported event that end cap, scn t2 scn was alleged of implant migration could not be confirmed.Although x-rays were repeatedly requested but not provided until time of investigation closure and thus, the reported event of unintended movement of end cap after implantation could not be verified.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: we received an end cap, scn t2 scn for evaluation.Detailed visual inspection revealed clear signs of usage.The windings show material abrasion [slight dents] and the inner side of hexagon shows scratches.Due to the nature of the returned device, a functional inspection was not possible.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.

• Brand Name: END CAP, SCN T2 SCN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8075190
• Report Number: 0009610622-2018-01397
• Device Sequence Number: 14034650
• Product Code: HSB
• UDI-Device Identifier: 04546540378613
• UDI-Public: 04546540378613
• Combination Product (Y/N): N
• PMA/510(K) Number: K023267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 18260003S
• Device Lot Number: K0973BF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/15/2019
• 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: Required Intervention