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

Model Number	1822-1130S
Medical Device Problem Codes	Separation Failure (2547); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the nail was attached to the handle backwards and would not come off.
Event or Problem Description
It was reported the nail was attached to the handle backwards and would not come off.
Additional 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
• 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
• 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
• Report Number: 0009610622-2021-00742
• Device Sequence Number: 19853863
• Product Code: HSB
• UDI-Device Identifier: 04546540198013
• UDI-Public: 04546540198013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown