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

Once the investigation has been completed any additional information will be reported 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 not be confirmed.The device inspection revealed the following: the device reported was received and evaluated and it was found that this device, locking screw (lot # k098da4), had no role in the overall event.Upon evaluation, the other locking screw (lot # k0caaf1) was found to be severely damaged with its threads flattened and stripped and it was found that the "spring" (wire) had come from this lot number (k0caaf1) screw only.The investigation for this device is included in mdr # 0009610622-2020-00061.

• 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: 9747210
• MDR Text Key: 191578220
• Report Number: 0009610622-2020-00060
• 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 Model Number: 1896-5040S
• Device Catalogue Number: 18965040S
• Device Lot Number: K098DA4
• 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