MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X47,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965047S

Device Problems Break (1069); Component Falling (1105); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

Patient is currently in constant pain in her right hip.Patient has welts on her hip that are hot to touch and painful.Patient can hear audible clicking/popping sounds.Patient's primary surgery was in (b)(6) 2014.On (b)(6) 2015 is was found that the rod fell in the leg, fractured the femur and opened up an old fracture.Patient had a revision in (b)(6) 2015 in which all parts were removed due to malfunction of hardware (as per surgeon).Patient is currently in a lot of pain and in need of a total hip replacement.Updated: received additional information: it was reported that rod fell in patient's leg.Top portion of where the bolt was broken.It was reported that patient did not fall.It was alleged that patient is allergic to some metals.

Manufacturer Narrative

Evaluation revealed that the item did not contribute to the complained event, therefore it was classified as concomitant item.Details of the evaluation are attached in investigation for the primary product.

Event Description

Patient is currently in constant pain in her right hip.Patient has welts on her hip that are hot to touch and painful.Patient can hear audible clicking/popping sounds.Patient's primary surgery was in (b)(6) of 2014.On (b)(6) 2015 is was found that the rod fell in the leg, fractured the femur and opened up an old fracture.Patient had a revision in (b)(6) of 2015 in which all parts were removed due to malfunction of hardware (as per surgeon).Patient is currently in a lot of pain and in need of a total hip replacement.Updated: received additional information: it was reported that rod fell in patient's leg.Top portion of where the bolt was broken.It was reported that patient did not fall.It was alleged that patient is allergic to some metals.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X47,5 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: 5801944
• MDR Text Key: 49758155
• Report Number: 0009610622-2016-00345
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965047S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 82 YR