MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X37,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5037S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: "when the long gamma implanted procedure, the screw was inserted as usual, but it broke in the middle.Only the shaft was remained inside the patient body.Since it was a hard bone".
Event or Problem Description
It was reported: "when the long gamma implanted procedure, the screw was inserted as usual, but it broke in the middle.Only the shaft was remained inside the patient body.Since it was a hard bone".
Additional Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed a broken locking screw.The device inspection revealed the following: the received screw is completely broken approx.Midshaft.The broken off part was not returned.Furthermore, the thread flank was found to be flattened and also signs of damage at the area under the screw head were verified.The appearance/structure of the breakage surface and the course of the breakage line suggest that the returned product broke in a brittle forced fracture, most likely due to a bending overload.Based on the above investigation, the root cause of the failure is related to a suboptimal intraoperative procedure [improper handling] and has to be classified as user-customer issue.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X37,5 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; GM D-24232
• MDR Report Key: 11862085
• Report Number: 0009610622-2021-00521
• Device Sequence Number: 14251507
• Product Code: HSB
• UDI-Device Identifier: 04546540382337
• UDI-Public: 04546540382337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 01/31/2026
• Device Model Number: 1896-5037S
• Device Catalogue Number: 18965037S
• Device Lot Number: K064DE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1