MAUDE Adverse Event Report: STRYKER GMBH RECONSTRUCTION PLATE, STRAIGHT HOLES 4 LENGTH 48MM FOR SCREWS Ø3.5/4.0MM; PLATE, FIXATION, BONE

Catalog Number 430104

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/22/2014

Event Type  Injury  

Manufacturer Narrative

This event was reported through an attorney, as a result of a legal claim.Due to the ongoing litigation no additional information is available at this time.If additional information is received it will be reported on a supplemental report.

Event Description

As reported: "plaintiffs allege that on or about (b)(6) 2014, (b)(6) was taken to (b)(6) hospital for treatment of injuries and fractures he sustained in a fall.Mr.(b)(6) underwent surgical treatment by surgeon for a left sub-trochanteric femur fracture and a left hip [orif].Records from the hospital indicate that surgeon utilized a stryker.11-hole wasted compression plate and.4-hole recon plate during the surgery on (b)(6) 2014, when she really wanted a "proximal femoral locking plate"." surgeon "was promised a "proximal femoral locking plate" by a sales representative but when it came time to use that plate, one was not available.Instead, surgeon ended up having to use [the 11-hole and the 4-hole plates].There is no allegation by plaintiffs, or the implanting surgeon, that these devices failed".A list of procedures performed on the patient identify a surgery on (b)(6) 2014 to "inspect and clean infected wound".

Manufacturer Narrative

The reported event that reconstruction plate, straight holes 4 length 48mm for screws ø3.5/4.0mm was alleged (infection) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ stryker has demonstrated that all implants, external fixation components, instruments, and trays that are delivered in a non-sterile condition can be successfully sterilized in any hospital or surgical facility with current sterilization techniques.A detailed description of approved sterilization techniques is described in the respective ifu.Sterilization of stryker implants and instruments is made in the full responsibility of the facility that has sterilized the devices in question.Stryker shall deny any responsibility in the case of an infection.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.The device history record could not be reviewed because the affected device was not returned and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "plaintiffs allege that on or about (b)(6)2014, r.D.Was taken to twin cities community hospital for treatment of injuries and fractures he sustained in a fall.Mr.D.Underwent surgical treatment by surgeon for a left sub-trochanteric femur fracture and a left hip [orif].Records from the hospital indicate that surgeon utilized a stryker.11-hole wasted compression plate and.4-hole recon plate during the surgery on(b)(6)2014 , when she really wanted a "proximal femoral locking plate"." surgeon "was promised a "proximal femoral locking plate" by a sales representative but when it came time to use that plate, one was not available.Instead, surgeon ended up having to use [the 11-hole and the 4-hole plates].There is no allegation by plaintiffs, or the implanting surgeon, that these devices failed".A list of procedures performed on the patient identify a surgery on (b)(6)2014to "inspect and clean infected wound".

• Brand Name: RECONSTRUCTION PLATE, STRAIGHT HOLES 4 LENGTH 48MM FOR SCREWS Ø3.5/4.0MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7404706
• MDR Text Key: 104662991
• Report Number: 0008031020-2018-00285
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K000636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 430104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention