MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS Ø7X270 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1830-0728S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It has been reported by the customer that the nail was broken.

Manufacturer Narrative

Correction: refer to d4.The reported event could be confirmed.The device inspection revealed the following: the received device was broken at a proximal end, the peg was torn off from the base.Signs of improper insertion were evident at the internal thread of the nail which shows that the target device was not assembled properly.Another peg appeared deformed due to external hitting.The fractured surface shows that the nail was broken due to excessive torsional force applied and several hitting on the nail¿s peg region during the disassembly of the nail to the target device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The failure was cause due to abnormal handling i.E.After improper alignment in between the nail and target device, excessive torsional force applied and several hitting on the nail¿s peg region during the disassembly of the nail to the target device.If any additional information is provided, the investigation will be reassessed.

Event Description

It has been reported by the customer that the nail was broken.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X270 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9398269
• MDR Text Key: 191686612
• Report Number: 0009610622-2019-00948
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540201348
• UDI-Public: 04546540201348
• Combination Product (y/n): N
• PMA/PMN Number: K032523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1830-0728S
• Device Catalogue Number: 18300727S
• Device Lot Number: K039AE4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1