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

Model Number	1896-5040S
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
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 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 or Problem 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).
Additional 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
• 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: 9747210
• Report Number: 0009610622-2020-00060
• Device Sequence Number: 19283226
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032244
• 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): 04/13/2020

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 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
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1