MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, RECON T2 RECON Ø6.5X110 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1897-6110S
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported, when the lag screw was inserted, it interfered with the screw hole of the nail and the screw tip was damaged.The broken tip was left inside the patient.The patient was young and his bone quality was good, so the direction was slightly deviated and could not be corrected.
Additional Manufacturer Narrative
The reported event, broken lag screw tip, was not confirmed since neither product nor medical records were provided.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).Implant breakage during insertion is rarely known.As reported the lag screw interfered with the drill hole of the nail which requires significant deviation between target device / sleeve and the nail¿s drill hole.Reasons are various like ¿ but not limited to ¿ insufficient tightened nail holding screw, k-wire initially deflected or significant manual load on the targeting construct during drilling which would be regarded as user related.Since a second lag screw was implanted successfully an inaccuracy in alignment of the target device can be excluded.A review of the device history for the reported lot did not indicate any abnormalities.As no products were returned an exact root cause could not be determined.In case product or other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a root cause.
Event or Problem Description
It was reported, when the lag screw was inserted, it interfered with the screw hole of the nail and the screw tip was damaged.The broken tip was left inside the patient.The patient was young and his bone quality was good, so the direction was slightly deviated and could not be corrected.

• Brand Name: LAG SCREW, RECON T2 RECON Ø6.5X110 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: 9659636
• Report Number: 0009610622-2020-00037
• Device Sequence Number: 3655190
• Product Code: HSB
• UDI-Device Identifier: 04546540384829
• UDI-Public: 04546540384829
• Combination Product (Y/N): N
• PMA/510(K) Number: K032898
• 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): 05/21/2020

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 Expiration Date: 11/30/2020
• Device Model Number: 1897-6110S
• Device Catalogue Number: 18976110S
• Device Lot Number: K05A053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1