MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18964040S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
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
It was reported that when the screw (1896-4040s) was inserted with screw driver, the head was stripped and the screw was not able to be advanced.Therefore, the new same screw was inserted.
Additional Manufacturer Narrative
The reported event that locking screw, fully threaded t2 tibia ø4x40 mm was alleged damaged and deformed could be confirmed.The screw comes back and shows a damaged thread and a damaged head.The visual inspection showed that the thread at the beginning of the screw tip has been damaged.Significant material deformation was found on a length of approx.16mm.The tips of the thread were nearly flattened down to the minor diameter; caused by significant resistance.This could have been caused by mal-alignment between locking screw and drill hole of the nail.In the screw head, the hexagon socket has been completely destroyed; caused by significant resistance.This could have been caused by mal-alignment between locking screw and drill hole of the nail.Generally, very high force had been applied to insert the distal screw.This was regarded as user related.Based on investigation, the root cause was attributed to a mechanical issue-jampositioning related issue.The failure was caused by user-customer-application errors; person makes a mistake, slip.All in-process inspection and the material inspection shows no deviation from specs.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.If any further information is provided, the complaint report will be updated.With given information a deficiency of the device was not verified.
Event or Problem Description
It was reported that when the screw (1896-4040s) was inserted with screw driver, the head was stripped and the screw was not able to be advanced.Therefore, the new same screw was inserted.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø4X40 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
• MDR Report Key: 8026440
• Report Number: 0009610622-2018-01372
• Device Sequence Number: 19207236
• Product Code: HSB
• UDI-Device Identifier: 04546540202406
• UDI-Public: 04546540202406
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 05/31/2023
• Device Catalogue Number: 18964040S
• Device Lot Number: K059301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR