MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X90 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965090

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem Impaired Healing (2378)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Surgeon reported to rep on (b)(6) 2017: 1 month after primary implant, x-rays taken on a followup visit showed that the screws were broken.Because the screws had broken so soon after the primary procedure, the fixation did not heal and became a nonunion.Surgeon removed the broken screws and the nail, and replaced with 2 screws and a nail.There were no delays to surgery and no adverse affects to patient (i.E.Pain, infection, et al) beyond revision.

Manufacturer Narrative

The evaluation revealed the broken t2 locking screws to be primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).During investigation no material, dimensional, visual or manufacturing related issues were found.The reported event was confirmed; the provided screws were completely broken in the shafts.All breakage surfaces were inspected in non-destructive manner.Macroscopic inspection revealed lines of rest and no plastic deformation on all breakage surfaces indicating fatigue fractures.Generally the risk of a breakage will increase with the increase of load cycles and load level.Screw breakage in general has been experienced, but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities - a screw breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.One requirement is that the implant must not be damaged during and after insertion.Surface damages reduce the implant¿s durability significantly.Another requirement is that the implant must not be stressed by too high load application e.G.(but not limited to) exceeding weight bearing or overweight or other stresses.The locking screws broke in fatigue fractures after different implantation periods.As the 3rd screw and the nail were not impaired by any breakages or significant deformations and according to the appearance of the shorter screw ¿ significant material deformation ¿ the screws had been significantly stressed by axial load.Review of complaint history, capa databases, labelling and risk analysis did not identify any discrepancies.There were no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.In case further information, should become available we will reopen the investigation.A product deficiency was not verified.

Event Description

Surgeon reported to rep on (b)(6) 2017: 1 month after primary implant, x-rays taken on a followup visit showed that the screws were broken.Because the screws had broken so soon after the primary procedure, the fixation did not heal and became a nonunion.Surgeon removed the broken screws and the nail, and replaced with 2 screws and a nail.There were no delays to surgery and no adverse affects to patient (i.E.Pain, infection, et al) beyond revision.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X90 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6915933
• MDR Text Key: 88232967
• Report Number: 0009610622-2017-00311
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032244
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965090
• Device Lot Number: K07F4BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention