MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1796-5040S
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Customer reported the following event: "when installing gamma nails, it is impossible to insert the distal screw through the nail.After several attempts to change the screw, the screw head is damaged but looks different from the new one as well as the screw pitch.The second is inserted without any difficulties".
Event or Problem Description
Customer reported the following event: "when installing gamma nails, it is impossible to insert the distal screw through the nail.After several attempts to change the screw, the screw head is damaged but looks different from the new one as well as the screw pitch.The second is inserted without any difficulties".
Additional Manufacturer Narrative
Correction: refer to d10/h3.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.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.No indications of material, manufacturing or design related problems were found during the investigation.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.Device disposition is unknown.

• Brand Name: LOCKING SCREW, FULLY THREADED S2 Ø5X40 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; DE D-24232
• MDR Report Key: 9387576
• Report Number: 0009610622-2019-00945
• Device Sequence Number: 16696179
• Product Code: HSB
• UDI-Device Identifier: 04546540399731
• UDI-Public: 04546540399731
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032579
• 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): 02/19/2020

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: 05/31/2024
• Device Model Number: 1796-5040S
• Device Catalogue Number: 17965040S
• Device Lot Number: K077CC3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1