MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA 10X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-1034S
Medical Device Problem Codes	Separation Failure (2547); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that : "stryker tibia nail fixation sleeve stuck in the tibia nail holder (1806-1002 - n°kh171892) and in the nail: impossible to unscrew them and therefore to place the nail (1822-1034s - n°k03f75c) in the patient, therefore change the size of the nail and place a nail without an ancillary.In the end, there is no clinical impact for the patient".
Event or Problem Description
The customer reported that : "stryker tibia nail fixation sleeve stuck in the tibia nail holder (1806-1002 - n°kh171892) and in the nail: impossible to unscrew them and therefore to place the nail (1822-1034s - n°k03f75c) in the patient, therefore change the size of the nail and place a nail without an ancillary.In the end, there is no clinical impact for the patient.".
Additional Manufacturer Narrative
D9/h3 were corrected to indicate this device was not available for return/evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.Although a real root cause could not be determined but the alleged event is most likely caused due to an oblique nhs [nail holding screw] insertion/cross threading/some debris inside the hole.The investigation of the parts returned and therefore available for a physical evaluation indicates that it is likely that the observed issue of seizing of the nail holding screw and resulting in an impaired disassembling is possible, if an unfavorable constellation of several dimensions (extreme value and specific direction) meet when assembling the devices.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.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.H3 other text : device disposition is unknown.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA 10X345 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
• MDR Report Key: 11641954
• Report Number: 0009610622-2021-00438
• Device Sequence Number: 14215991
• Product Code: HSB
• UDI-Device Identifier: 04546540197917
• UDI-Public: 04546540197917
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 07/31/2024
• Device Model Number: 1822-1034S
• Device Catalogue Number: 18221034S
• Device Lot Number: K03F75C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1