MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE LISFRANC / MEDIUM - RIGHT; PLATE, FIXATION, BONE

Catalog Number	PLP30172
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the surgeon made a lisfranc operation with the anchorage foot plating system.The plate was already implemented in the patient with three locking screws and one cortical screw.The last lock screw "corked" through the locking hole so that it no longer locked onto the plate.Surgeon decided to remove the plate and all the screws and replace them with new ones.The new plate and screws worked fine.Surgical delay approx.10 minutes.Plate and screws were removed and replaced with new ones.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
It was reported that the surgeon made a lisfranc operation with the anchorage foot plating system.The plate was already implemented in the patient with three locking screws and one cortical screw.The last lock screw "corked" through the locking hole so that it no longer locked onto the plate.Surgeon decided to remove the plate and all the screws and replace them with new ones.The new plate and screws worked fine.Surgical delay approx.10 minutes.Plate and screws were removed and replaced with new ones.

• Brand Name: PLATE ANCHORAGE LISFRANC / MEDIUM - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8246270
• Report Number: 0008031020-2019-00025
• Device Sequence Number: 19319569
• Product Code: HRS
• UDI-Device Identifier: 07613252260837
• UDI-Public: 07613252260837
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLP30172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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