MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X300 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1822-1130S

Device Problems Separation Failure (2547); Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported the nail was attached to the handle backwards and would not come off.

Event Description

It was reported the nail was attached to the handle backwards and would not come off.

Manufacturer Narrative

The reported event could be not confirmed, since the product was not returned for evaluation.The device inspection was not possible as the product was not returned for investigation.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.The information for use states that ¿careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.Do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! always treat the instrument carefully to avoid surface damage or alterations to the geometry.¿ no indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.H3 other text : device disposition is unknown.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X300 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12590478
• MDR Text Key: 275180616
• Report Number: 0009610622-2021-00742
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540198013
• UDI-Public: 04546540198013
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1822-1130S
• Device Catalogue Number: 18221130S
• Device Lot Number: K0B9164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2018
• 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