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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.
Event or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8084080
• Report Number: 0008031020-2018-00985
• Device Sequence Number: 1203568
• Product Code: HRS
• UDI-Device Identifier: 04546540368447
• UDI-Public: 04546540368447
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K000636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 430106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR