MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X85 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18955085S

Device Problems Break (1069); Difficult to Insert (1316); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

During t2 surgery, the condyle screw and the washer got stuck and became impossible further insertion.Then , the condyle screw broke when removing.The surgery was continued with another new ones.

Manufacturer Narrative

The evaluation revealed the condyle screw nut and condyle screw to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The implants returned were documented as faultless prior to distribution.During investigation no material, dimensional or manufacturing related issues were found.The condyle screw broke at its thread; the main part of the screw thread was found jammed within the nut reception.Deformations of the screw windings and the breakage surface indicate that the screw broke due to a torsional overload.Furthermore the windings got partly damaged by contacting the nail hole rim during implantation.Additionally a part of the nut rim got bulged into the nut reception by the screw tip so that a part broke off and got jammed between the screw thread and nut reception.The screw thread windings are partly flattened as a design feature; the flattened windings shall perform a safety lock within the nut inner thread to guarantee that both implants didn¿t become detached postoperatively.The abraded and deformed screw thread windings, furthermore the jammed nut rim part caused unintended forces and stresses to the material during screw insertion to a level that it got overloaded resulting in the breakage of the screw.Ifu and operative technique includes that the implants shall be combined, handled and secured with care; that the user shall be familiar with the system.The operative technique describes the correct assembling of the implants in detail.Because no manufacturer related issue was found the case is attributed to an inadequate usage (use error).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).No non-conformity was identified.

Event Description

During t2 surgery, the condyle screw and the washer got stuck and became impossible further insertion.Then, the condyle screw broke when removing.The surgery was continued with another new ones.

• Brand Name: CONDYLE SCREW T2 FEMUR Ø5X85 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6401184
• MDR Text Key: 70072644
• Report Number: 0009610622-2017-00078
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K014220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 18955085S
• Device Lot Number: K0789C7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR