MAUDE Adverse Event Report: STRYKER GMBH RECONSTRUCTION PLATE, STRAIGHT HOLES 6 LENGTH 72MM FOR SCREWS Ø3.5/4.0MM; PLATE, FIXATION, BONE

Catalog Number 430106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.

Event Description

The customer reported that the surgeon implanted a recon plate instead of a waisted compression plate into the wrist of a patient.The items are positioned in similar places on the small fragment set tray and have a similar appearance when viewed side by side and as such the wrong plate was handed to the surgeon in error.Indication for the primary surgery: both bone mid/distal 1/3rd forearm fracture (right) fracture not united but in reasonable alignment at 10 weeks.Significant risk of requiring revision.Under review.430106 implanted instead of 430006.

• Brand Name: RECONSTRUCTION PLATE, STRAIGHT HOLES 6 LENGTH 72MM FOR SCREWS Ø3.5/4.0MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8084080
• MDR Text Key: 127552079
• Report Number: 0008031020-2018-00985
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540368447
• UDI-Public: 04546540368447
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K000636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018

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: 430106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/19/2018
• 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): Other
• Patient Age: 48 YR