MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LAG SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Collapse (2416)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's left femur was revised due to collapse of the patient's existing femoral fracture.Rep confirmed there are no allegations against the implants.Surgeon reported complicating factors as patient emaciation with virtually no muscle, and patient non-compliance in terms of follow-up visits.Patient was converted from a short gamma nail construct to a total hip.Rep reported that no further information is available.Procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: UNKNOWN LAG SCREW
• Type of Device: IMPLANT
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9187855
• MDR Text Key: 162840912
• Report Number: 0009610622-2019-00865
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• 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: 74 YR
• Patient Weight: 38