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

Catalog Number 31251180S

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported by the nurse of the hospital, that the locking pin 3125-1180s was missing.

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 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°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 5691555
• MDR Text Key: 46300996
• Report Number: 0009610622-2016-00280
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153313274
• UDI-Public: 0107613153313274111508311720073110K0897DB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other