MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_KIE_PRODUCT; IMPLANT

Catalog Number UNK_KIE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/27/2013

Event Type  Injury  

Event Description

It was reported that due to a mistake, supposedly caused by the hospital`s sterilization department, the subject received a 4 -hole dhs side plate made by synthes which was combined with a lag screw made by stryker.Since those two components are not compatible, the implant failed which required an additional surgical intervention (i.E.Revision surgery) seven days after the initial surgery during which the subject received a new stryker omega3 s-hole dhs including a compatible stryker lag screw.

Manufacturer Narrative

Investigation evaluation: the reported event that the stryker screw was used with a non stryker plate could not be confirmed, since the device was not returned for evaluation.Based on the investigation, the root cause of the reported event was attributed to a user related issue.It was reported that the healthcare facility mistakenly used a stryker screw with a non stryker plate which was not compatible.The instructions for use states: ¿do not use components of the stryker osteosynthesis product systems in conjunction with components from any other manufacturers¿ system unless otherwise specified.The operative technique for the omega 3 system compression hip screw lists no components from other manufacturers as being compatible with the omega 3 system.A review of the device history was not performed because the lot number and catalog number were not communicated, and because the reported event did not allege a product failure or manufacturing defect.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

• Brand Name: UNKNOWN_KIE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose mincieli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3603042
• MDR Text Key: 18623473
• Report Number: 0009610622-2014-00052
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/03/2014
• 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: 85 YR
• Patient Weight: 62