MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.0MM / L20MM; PLATE, FIXATION, BONE

Catalog Number	PLSL3020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
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
Correction: cat#, lot# the reported event that locking screw anchorage ø3.0mm / l20mm was alleged of 'poor fixation' could be confirmed.The root cause of this positioning issue has been identified as user related.When too much torque is applied during screw insertion, it can happen that the screw goes through the plate.Please note that operative technique an-st-1 en rev 2 anchorage op tech reads: all threaded holes can accommodate either locking or non locking screws (3.0mm and 3.5mm diameter).The compression ramp only accepts 3.0mm non locking screws.Applying excessive torque during screw insertion is not recommended, and may result in damage to the screw head.In particular for non locking screws it is recommended to tighten the screw head until contact with the plate, then release from tightening.However, it was identified that under certain circumstances, the screw might slip through the plates.This might lead to prolongation of surgery time (less than 15 minutes) and in rare cases a bone damage due to an unused screw hole can occur.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: LOCKING SCREW ANCHORAGE Ø3.0MM / L20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8246189
• Report Number: 0008031020-2019-00023
• Device Sequence Number: 19192402
• Product Code: HRS
• UDI-Device Identifier: 07613252262176
• UDI-Public: 07613252262176
• 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): 03/26/2019

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: PLSL3020
• Device Lot Number: V32079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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