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 Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Non-union Bone Fracture (2369)

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 surgeon reported that a recon plate has been implanted in stead of the waisted compression plate and the surgeon alleges that this has happened because the plates look similar.430106 was implanted instead of 430006.**update** male lost to follow up at 6 months with incomplete union.Indication for surgery: midshaft # radius with druj dislocation.Delayed union as per ct on (b)(6) 2017 then loss to follow-up; outcome uncertain.Incomplete union seen on ct (b)(6) 2017 before ltfa.Moderately symptomatic when last seen (b)(6) 2017.Patient needs clinical review.

Manufacturer Narrative

The reported event that reconstruction plate, straight holes 6 length 72mm for screws ø3.5/4.0mm was alleged of 'wrong device used' could be confirmed only according to the given feedback from the hospital, despite that the product was not returned.Based on investigation, the root cause was attributed to be user related.The failure was caused by an user error as the wrong plate was taken out of the tray and used (a recon plate instead of a waisted compression plate).Original statement from our medical expert: more detailed information should be known in order to be able to give a sound answer to this occurrence.In general i would think that no major problems are associated with this wrong choice.In some cases the plates have to be bend for final exact fixation anyway but in the end the doctor and the other hcp involved are responsible which device they use.A review of the device history was not possible because the lot number was not communicated.Note that this only happened in this particular hospital, therefore the relevant hospital staff needs to undergo a training (¿user ¿ customer - learning gaps errors ; lack of knowledge skills¿) in order to eliminate such problems.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The surgeon reported that a recon plate has been implanted in stead of the waisted compression plate and the surgeon alleges that this has happened because the plates look similar.430106 was implanted instead of 430006.**update** male lost to follow up at 6 months with incomplete union.Indication for surgery: midshaft # radius with druj dislocation delayed union as per ct on (b)(6)2017 then loss to follow-up; outcome uncertain incomplete union seen on ct (b)(6)2017 before ltfa.Moderately symptomatic when last seen apr 2017.Patient needs clinical review.

• 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
• MDR Report Key: 8056749
• MDR Text Key: 126893227
• Report Number: 0008031020-2018-00972
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention