MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1896-5040S

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Customer reported that : "during the removal of the titanium nail installed on (b)(6) 2019, a spring appears next to the titanium screw corresponding to the thread that has come loose." additionally reported: procedure completed successfully.No patient consequences.Delay : 5min, time to determine where this metal piece came from no other medical intervention.Spring came from locking screw.Removal of the nail within the consolidation period ((b)(6) patient, nail installed on (b)(6) 2018).

Event Description

Customer reported that : "during the removal of the titanium nail installed on (b)(6) 2019, a spring appears next to the titanium screw corresponding to the thread that has come loose." additionally reported: procedure completed successfully.No patient consequences.Delay : 5min, time to determine where this metal piece came from no other medical intervention.Spring came from locking screw.Removal of the nail : removal of the nail within the consolidation period (18yearold patient, nail installed on (b)(6) 2018).

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received locking screw shows severe deformation.More than half of threads have been deformed and flattened.The topmost deformed threads show rough edges which happened due to stripping of some metal in the form of the wire.This stripped wire was recovered intact with its number of turns corresponding to number of turns from the point where it started forming in the screw.Such stripping and deformation are only possible when there is a direct metal to metal contact.Upon closer look of the received nail, at the distal part, the a/p hole shows signs of damage which clearly indicates its interaction with the locking screw under immense force.Based on the above investigation, the root cause of the failure is user related.Additionally concluded; this is a case of intra-op misalignment by the operating surgeon, where during distal free-hand locking, the locking screw was mis-aligned and slightly came in contact with the a/p hole.As a result of this interaction, immense force was needed to insert the screw inside which led to stripping of threads (wire formation upon metal-metal contact).As reported in the event, it was found that the screw had come loose, which was due to loss of metal from screw threads in the form of the wire.A review of the labeling did not indicate any abnormalities.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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; DE D-24232
• MDR Report Key: 9748377
• MDR Text Key: 191577377
• Report Number: 0009610622-2020-00061
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1896-5040S
• Device Catalogue Number: 18965040S
• Device Lot Number: K0CAAF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1