MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251180S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the nurse of the hospital, that the locking pin 3125-1180s was missing.
Additional Manufacturer Narrative
The evaluation revealed the nail kit of the provided package to be the primary product (a different nail kit was originally complained - cat# 3125-1180s).No deviations were found during review of the manufacturing and inspection documents (dhr).The nail kit of the provided package labelling was documented as faultless prior to distribution; the set screw was documented as inserted.The microscopically inspection of the provided plastic blister revealed that a shape of a set screw is visible; furthermore micro-damaged, caused by the set screw thread windings, hitting the plastic during transport movement.Therefore a set screw was inserted within the blister; the complained missing of the set screw could not be confirmed.Most likely the set screw popped out of the package due to rough opening or due to opening upside down (use error).Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
Event or Problem Description
It was reported by the nurse of the hospital, that the locking pin 3125-1180s was missing.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
• 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: 5691555
• Report Number: 0009610622-2016-00280
• Device Sequence Number: 18940277
• Product Code: HSB
• UDI-Device Identifier: 07613153313274
• UDI-Public: 0107613153313274111508311720073110K0897DB
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2016

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: 07/31/2020
• Device Catalogue Number: 31251180S
• Device Lot Number: K0897DB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 07/27/2016
• 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