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

Model Number	1826-0003S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
Event or Problem Description
As reported; "about 10 years ago, the patient inserted a t2 supra condilla nail at another hospital, and over the years, the end cap had fallen off and was in the joint.Additional information received: did the loose cap had been loose in the joint during the last 10 years or more recently? it loosen recent years.Any plans for medical intervention to remove the end cap? the information is unavailable, if the end cap is going to remove or not.

• 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; GM D-24232
• MDR Report Key: 11207338
• Report Number: 0009610622-2021-00241
• Device Sequence Number: 11895213
• Product Code: HSB
• UDI-Device Identifier: 04546540378613
• UDI-Public: 04546540378613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023267
• 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
• Report Date (Section B): 01/21/2021

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: Lay User/Patient
• Device Model Number: 1826-0003S
• Device Catalogue Number: 18260003S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1