MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT ACETABULAR PLATE HOLES 18 LENGTH 214.5MM FOR SCREWS Ø3.5/4.5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number	425768
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.
Event or Problem Description
Orif of fracture of the pelvis ring with use of stryker plates (matta, 18 holes flexplate).The received photo confirms the plate to be broken.
Event or Problem Description
Orif of fracture of the pelvis ring with use of stryker plates (matta, 18 holes flexplate).The received photo confirms the plate to be broken.
Additional Manufacturer Narrative
Concomitant medical products and device evaluated by mfr the reported event that straight acetabular plate holes 18 length 214.5mm for screws ø3.5/4.5mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the use of improper equipment to bend the plate, or a misuse of the stryker equipment.The device inspection revealed the following: the plate is heavily twisted and bent in all planes.It is broken at the level of the 8th hole.Only one half of the plate has been returned.The broken plate shows a lot of deep scratches, uncommon to the type of scratched the recommended (stryker pro-matta) plate benders cause.Furthermore, the way the plate was bent was not usual to the way the use of stryker plate benders result in.A test was made on a brand new pelvis plate (catalog# 425758, lot # w35866) using a new stryker pro plate bender (703970), an older version of plate bender (702903) and a free hand bending of the plate.All these plate benders caused some slight scratching of the surface of the plate, but none as severe as the ones that can be noticed on the broken plate.The use of an inadequate plate bender or the misuse of stryker plate benders could most possibly be the root cause of the reported breakage.Moreover, a microscope inspection was used to analyses the breakage surface of the breakage area: shiny surfaces can be noticed, which prove that after the plate broke gradually and that the two parts of the plate rubbed against each other for a while, before it broke completely.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 any further information is provided, the investigation report will be updated.

• Brand Name: STRAIGHT ACETABULAR PLATE HOLES 18 LENGTH 214.5MM FOR SCREWS Ø3.5/4.5MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7607269
• Report Number: 0008031020-2018-00470
• Device Sequence Number: 2142028
• Product Code: KTW
• UDI-Device Identifier: 04546540413703
• UDI-Public: 04546540413703
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K001614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 425768
• Device Lot Number: J14753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 85